COMFORT-B Scores Research Articles

Prospective observational study on the use of continuous intravenous ketamine and propofol infusion for prolonged sedation in critical care

IntroductionAnalgesia and sedation are a priority in paediatric intensive care. The combination of ketamine and propofol is a possible option in patients requiring prolonged or difficult sedation and to reduce the use of benzodiazepines and opiates. The aim of this study was to assess the efficacy and safety of combination ketamine and propofol in continuous infusion for prolonged analgesia/sedation in the paediatric intensive care setting. Patients and methodsProspective, observational single-group cohort study in patients aged 1 month to 16 years admitted to the paediatric intensive care unit in 2016–2018 that received ketamine and propofol in continuous infusion for analgesia and sedation. We collected data on demographic and clinical characteristics, analgesia and sedation scores (MAPS, COMFORT-B and SOPHIA), haemodynamic parameters and adverse events. ResultsThe study included 32 patients. The maximum dose of ketamine was 1.5 mg/kg/h (interquartile range [IQR], 1−2 mg/kg/h) and the infusion duration was 5 days (IQR, 3–5 days). The maximum dose of propofol was 3.2 mg/kg/h (IQR, 2.5–3.6 mg/kg/h) and the infusion duration, 5 days (IQR, 3–5 days). Thirty (93.7%) patients had previously received midazolam and 29 (90.6%) fentanyl. Analgesia scores did not change after initiation of the ketamine and propofol infusion. There was a statistically significant increase in the COMFORT-B score, but the score remained in the adequate sedation range (12–17). There were small but statistically significant decreases in the mean arterial pressure (from 64 mmHg to 60 mmHg; P = .006) and the diastolic blood pressure (from 50.5 to 48 mmHg; P = .023) 1 h after the initiation of the ketamine and propofol infusion, but this difference was not observed 12 h later and did not require administration of vasoactive drugs. No other major adverse events were detected during the infusion. ConclusionsThe combination of ketamine and propofol in continuous infusion is a safe treatment in critically ill children that makes it possible to achieve an appropriate level of analgesia and sedation without relevant haemodynamic repercussions.

Uso concomitante de ketamina y propofol en perfusión continua en cuidados intensivos: eficacia y seguridad para analgesia y sedación prolongada

IntroductionAnalgesia and sedation are a priority in paediatric intensive care. The combination of ketamine and propofol is a possible option in patients requiring prolonged or difficult sedation and to reduce the use of benzodiazepines and opiates. The aim of this study was to assess the efficacy and safety of combination ketamine and propofol in continuous infusion for prolonged analgesia/sedation in the paediatric intensive care setting. Patients and methodsProspective, observational single-group cohort study in patients aged 1 month to 16 years admitted to the paediatric intensive care unit in 2016–2018 that received ketamine and propofol in continuous infusion for analgesia and sedation. We collected data on demographic and clinical characteristics, analgesia and sedation scores (MAPS, COMFORT-B and SOPHIA), haemodynamic parameters and adverse events. ResultsThe study included 32 patients. The maximum dose of ketamine was 1.5mg/kg/h (interquartile range [IQR], 1–2mg/kg/h) and the infusion duration was 5 days (IQR, 3–5 days). The maximum dose of propofol was 3.2mg/kg/h (IQR, 2.5–3.6mg/kg/h) and the infusion duration, 5 days (IQR, 3–5 days). Thirty (93.7%) patients had previously received midazolam and 29 (90.6%) fentanyl. Analgesia scores did not change after initiation of the ketamine and propofol infusion. There was a statistically significant increase in the COMFORT-B score, but the score remained in the adequate sedation range (12–17). There were small but statistically significant decreases in the mean arterial pressure (from 64mmHg to 60mmHg; P=.006) and the diastolic blood pressure (from 50.5 to 48mmHg; P=.023) 1h after the initiation of the ketamine and propofol infusion, but this difference was not observed 12h later and did not require administration of vasoactive drugs. No other major adverse events were detected during the infusion. ConclusionsThe combination of ketamine and propofol in continuous infusion is a safe treatment in critically ill children that makes it possible to achieve an appropriate level of analgesia and sedation without relevant haemodynamic repercussions.

Midazolam Infusion and Disease Severity Affect the Level of Sedation in Children: A Parametric Time-to-Event Analysis

AimIn critically ill mechanically ventilated children, midazolam is used first line for sedation, however its exact sedative effects have been difficult to quantify. In this analysis, we use parametric time-to-event (PTTE) analysis to quantify the effects of midazolam in critically ill children.MethodsIn the PTTE analysis, data was analyzed from a published study in mechanically ventilated children in which blinded midazolam or placebo infusions were administered during a sedation interruption phase until, based on COMFORT-B and NISS scores, patients became undersedated and unblinded midazolam was restarted. Using NONMEM® v.7.4.3., restart of unblinded midazolam was analysed as event. Patients in the trial were divided into internal and external validation cohorts prior to analysis.ResultsData contained 138 events from 79 individuals (37 blinded midazolam; 42 blinded placebo). In the PTTE model, the baseline hazard was best described by a constant function. Midazolam reduced the hazard for restart of unblinded midazolam due to undersedation by 51%. In the blinded midazolam group, time to midazolam restart was 26 h versus 58 h in patients with low versus high disease severity upon admission (PRISM II < 10 versus > 21), respectively. For blinded placebo, these times were 14 h and 33 h, respectively. The model performed well in an external validation with 42 individuals.ConclusionThe PTTE analysis effectively quantified the effect of midazolam in prolonging sedation and also the influence of disease severity on sedation in mechanically ventilated critically ill children, and provides a valuable tool to quantify the effect of sedatives.Clinical trial number and registry URL: Netherlands Trial Register, Trial NL1913 (NTR2030), date registered 28 September 2009 https://www.trialregister.nl/trial/1913.

Sufentanil Disposition and Pharmacokinetic Model-Based Dosage Regimen for Sufentanil in Ventilated Full-Term Neonates

Introduction: Sufentanil is a potent synthetic opioid used for analgesia in neonates; however, data concerning drug disposition of sufentanil and dosage regimen are sparse in this population. Therefore, the aim of the study was to explore sufentanil disposition and to propose optimal loading and maintenance doses of sufentanil in ventilated full-term neonates. Methods: Individual sufentanil pharmacokinetic parameters were calculated based on therapeutic drug monitoring data using a 2-compartmental model. Linear regression models were used to explore the covariates. Results: The median (IQR) central volume of distribution (Vd_c) and clearance (CL) for sufentanil were 4.7 (4.1–5.4) L/kg and 0.651 (0.433–0.751) L/h/kg, respectively. Linear regression models showed relationship between Vd_c (L) and GA (r² = 0.3436; p = 0.0452) as well as BW (r² = 0.4019; p = 0.0268). Median optimal sufentanil LD and MD were 2.13 (95% CI: 1.78–2.48) μg/kg and 0.29 (95% CI: 0.22–0.37) μg/kg/h, respectively. Median daily COMFORT-B (IQR) scores ranged from 6 to 23 while no significant relationship between pharmacokinetic parameters and COMFORT-B scores was found. Discussion/Conclusion: Body weight and gestational age were found as weak covariates for sufentanil distribution, and the dosage regimen was developed for a prospective trial.

The performance of the heart rate variability-derived Newborn Infant Parasympathetic Evaluation Index as a measure of early postoperative pain and discomfort in infants-A prospective observational study.

BackgroundThe heart rate variability‐derived Newborn Infant Parasympathetic Evaluation (NIPE™) Index is a continuous noninvasive tool for the assessment of pain and discomfort in infants. Little is known about its performance in the early postoperative setting, where assessment of pain/discomfort is usually based on discontinuous observational scoring systems or personal experience of medical staff.AimsTo investigate the performance of the NIPE as a measure of early postoperative pain and/or discomfort in infants.MethodsThe potential of the NIPE to detect pain/discomfort, as assessed by two clinical scoring systems (FLACC and COMFORT‐B scale), was investigated in postoperative infants (0–2 years).ResultsReceiver operating curve (ROC) analyses investigating the power of the NIPE to distinguish between comfort and pain/discomfort, revealed areas under the curve (AUC) of 0.77 for the FLACC, 0.81 for the COMFORT‐B score, and 0.77 for a combination of FLACC & COMFORT‐B. Logistic regression analysis provided initial evidence that the NIPE is an independent predictor of a FLACC score ≥4 and/or a COMFORT‐B score ≥17, though R 2 values were below .2. NIPE values associated with a FLACC ≥4 (48 [45–56]), a COMFORT‐B score ≥17 (47 [42–53]), and a FLACC ≥4 & COMFORT‐B ≥17 (47 [42–57]) were lower than NIPE values associated with a FLACC <4 (60 [53–68], 95% CI of difference −14 to −8, p < .0001), a COMFORT‐B score <17 (61 [54–68], 95% CI of difference −16 to −10, p < .0001), and a FLACC <4 & COMFORT‐B score <17 (60 [53–68], 95% CI of difference −15 to −8, p < .0001). We found no evidence of a predictive value of the NIPE regarding the occurrence of pain.ConclusionsThe NIPE detected pain and discomfort in infants after general anesthesia with reasonable areas under the ROC curve (±0.8), whereas it was not predictive of clinically detectable pain or discomfort.

Bilateral ultrasound-guided thoracic erector spinae plane blocks using a programmed intermittent bolus improve opioid-sparing postoperative analgesia in pediatric patients after open cardiac surgery: a randomized, double-blind, placebo-controlled trial

BackgroundPostoperative pain after pediatric cardiac surgery is usually treated with intravenous opioids. Recently, the focus has been on postoperative regional analgesia with the introduction of ultrasound-guided erector spinae plane blocks...

Pharmacokinetics and Sedative Effects of Intranasal Dexmedetomidine in Ambulatory Pediatric Patients.

Our aim was to characterize the pharmacokinetics and sedative effects of intranasally (IN) administered dexmedetomidine used as an adjuvant in pediatric patients scheduled for magnetic resonance imaging (MRI) requiring sedation. This was an open-label, single-period study without randomization. Pediatric patients from 5 months to 11 years of age scheduled for MRI and receiving IN dexmedetomidine for premedication as part of their care were included in this clinical trial. Single doses of 2-3 µg·kg of dexmedetomidine were applied IN approximately 1 hour before MRI. Five or 6 venous blood samples were collected over 4 hours for dexmedetomidine concentration analysis. Sedation was monitored with Comfort-B scores, and vital signs were recorded. Pharmacokinetic variables were calculated with noncompartmental methods and compared between 3 age groups (between 1 and 24 months, from 24 months to 6 years, and over 6-11 years). We evaluated 187 consecutive patients for suitability, of which 132 were excluded. Remaining 55 patients were recruited, of which 5 were excluded before the analysis. Data from 50 patients were analyzed. The average (standard deviation [SD]) dose-corrected peak plasma concentration (Cmax) was 0.011 liter (0.0051), and the median (interquartile range [IQR]) time to reach peak concentration (tmax) was 37 minutes (30-45 minutes). There was negative correlation with Cmax versus age (r = -0.58; 95% confidence interval [CI], -0.74 to -0.37; P < .001), but not with tmax (r = -0.14; 95% CI, 0.14-0.39; P = .35). Dose-corrected areas under the concentration-time curve were negatively correlated with age (r = -0.53; 95% CI, 0.70 to -0.29; P < .001). Median (IQR) maximal reduction in Comfort-B sedation scores was 8 (6-9), which was achieved 45 minutes (40-48 minutes) after dosing. Median (IQR) decrease in heart rate was 15% (9%-23%) from the baseline. Dexmedetomidine is relatively rapidly absorbed after IN administration and provides clinically meaningful but short-lasting sedation in pediatric patients.

Dexmedetomidine is effective and safe during NIV in infants and young children with acute respiratory failure

BackgroundNoninvasive ventilation (NIV) is increasingly utilized in infants and young children, though associated with high failure rates due to agitation and poor compliance, mostly if patient-ventilator synchronization is required.MethodsA retrospective cohort study was carried out in an academic pediatric intensive care unit (PICU). Dexmedetomidine (DEX) was infused as unique sedative in 40 consecutive pediatric patients (median age 16 months) previously showing intolerance and agitation during NIV application.ResultsDuring NIV clinical application both COMFORT-B Score and Richmond Agitation-Sedation Scale (RASS) were serially evaluated. Four patients experiencing NIV failure, all due to pulmonary condition worsening, required intubation and invasive ventilation. 36 patients were successfully weaned from NIV under DEX sedation and discharged from PICU. All patients survived until home discharge.ConclusionOur data suggest that DEX may represent an effective sedative agent in infants and children showing agitation during NIV. Early use of DEX in infants/children receiving NIV for acute respiratory failure (ARF) should be considered safe and capable of improving NIV, thus permitting both lung recruitment and patient-ventilator synchronization.

Oral lorazepam can be substituted for intravenous midazolam when weaning paediatric intensive care patients off sedation.

AimIntravenous sedatives used in the paediatric intensive care unit (PICU) need to be tapered after prolonged use to prevent iatrogenic withdrawal syndrome (IWS). We evaluated the occurrence of IWS and the levels of sedation before and after conversion from intravenous midazolam to oral lorazepam.MethodsThis was a retrospective, observational, single cohort study of children under the age of 18 admitted to the PICU of the Erasmus MC‐Sophia Children's Hospital, Rotterdam, The Netherlands, between January 2013 and December 2014. The outcome parameters were the Sophia Observation withdrawal Symptoms (SOS) scale scores and COMFORT Behaviour scale scores before and after conversion.ResultsOf the 79 patients who were weaned, 32 and 39 had before and after SOS scores and 77 had COMFORT‐B scores. IWS was reported in 15 of 79 patients (19.0%) during the 48 hours before the start of lorazepam and 17 of 79 patients (21.5%) during the 48 hours after treatment started. Oversedation was seen in 16 of 79 patients (20.3%) during the 24 hours before substitution and in 30 of 79 patients (38.0%) during the 24 hours after substitution.ConclusionThe weaning protocol was not able to prevent IWS in all patients, but converting from intravenous midazolam to oral lorazepam did not increase the incidence.

Is phototherapy stressful? A study to compare the stress of neonates in single and double-surface phototherapy

Objectives: The aim of this study is to compare the stress level of neonate undergoing double-surface (DS) and single-surface (SS) phototherapy. Study Design: This was a prospective observational study. Study Setting: Neonates with indirect hyperbilirubinemia on phototherapy in Special Newborn Care Unit of Christian Hospital, Chhatarpur, Madhya Pradesh, India (A Unit of Emmanuel Hospital Association, New Delhi). Materials and Methods: The stress level of neonate under DS and SS phototherapy was assessed with COMFORT-B scale. The neonate was assessed before the start of phototherapy (zero hours) and was further assessed at 2, 6, 12, and 24 h of phototherapy. Results: A total of 94 neonates were included in the study, of which 56 (59.5%) are term and 38 (40.5%) are preterm. The maximum COMFORT-B scale score was 23, and the minimum score was 7. The mean COMFORT-B score was marginally higher with DS phototherapy at all hours of phototherapy, but it is not statistically significant. Similar observations were noted among terms and preterms. Conclusion: There is no additional stress to neonates in DS phototherapy compared to SS phototherapy.

Pharmacokinetics of S-ketamine during prolonged sedation at the pediatric intensive care unit.

S-ketamine is the S(+)-enantiomer of the racemic mixture ketamine, an anesthetic drug providing both sedation and analgesia. In clinical practice, significant interpatient variability in drug effect of S-ketamine is observed during long-term sedation. The aim of this study was to evaluate the pharmacokinetic variability of S-ketamine in children aged 0-18years during long-term sedation. Twenty-five children (median age: 0.42years, range: 0.02-12.5) received continuous intravenous administrations of 0.3-3.6mg/kg/h S-ketamine for sedation during mechanical ventilation. Infusion rates were adjusted to the desired level of sedation and analgesia based on the COMFORT-B score and Visual Analog Scale. Blood samples were drawn once daily at random time-points, and at 1 and 4hours after discontinuation of S-ketamine infusion. Time profiles of plasma concentrations of S-ketamine and active metabolite S-norketamine were analyzed using nonlinear mixed-effects modeling software. Clearance and volume of distribution were allometrically scaled using the ¾ power model. A total of 86 blood samples were collected. A 2-compartment and 1-compartment model adequately described the PK of S-ketamine and S-norketamine, respectively. The typical parameter estimates for clearance and central and peripheral volumes of distribution were: CLS-KETAMINE =112L/h/70kg, V1S-KETAMINE =7.7L/70kg, V2S-KETAMINE =545L/70kg, QS-kETAMINE =196L/h/70kg, and CLS-NORKETAMINE =53L/h/70kg. Interpatient variability of CLS-KETAMINE and CLS-NORKETAMINE was considerable with values of 40% and 104%, respectively, leading to marked variability in steady-state plasma concentrations. Substantial interpatient variability in pharmacokinetics in children complicates the development of adequate dosage regimen for continuous sedation.

Assessing and addressing the problem of pain and distress during wound care procedures in paediatric patients with burns

ObjectiveWhile the prevalence of burns in children is highest in low and middle-income countries, most research on burn-related pain intensity and distress is carried out in high-income countries. In this study we assessed pain intensity and distress in paediatric patients with burns undergoing wound care procedures without distraction and parental presence in a South-African children’s hospital and sought to identify predictors for the outcomes. MethodsThis observational study, carried out as part of a randomized controlled trial, took place at a burns unit in Cape Town, South Africa and included patients between the ages of 0 and 13 years undergoing their first or second wound care procedure. We measured pain intensity and distress using the COMFORT Behavioural scale (COMFORT-B) across four distinct phases of wound care procedures: removal of bandage; washing the wound; administering wound care; putting on new dressings. COMFORT-B scores ≥21 indicate severe pain intensity and distress. Results124 patients were included, median age 21.2 months (IQR 14.9–39.5 months), 90% suffered scalds, and median total body surface 8% (IQR 5–14%). Assessment scores for the majority of patients were indicative of severe pain intensity and distress during wound care procedures. Median COMFORT-B scores across the four phases were 24, 25, 25 and 22 respectively. Across the four phases respectively 76%; 89%; 81% and 62% of the patients were indicated with severe pain intensity and distress. Age was a predictor for pain intensity and distress as younger children were assigned higher scores than older children (Unstandardized B −.052; 95% CI −.071 to −.032 p<0.001). ConclusionsIn this study children received wound care procedures without distraction or parental presence and were assessed to have high pain intensity and distress. There is a correlation between age and COMFORT-B scores: younger children show higher distress, indicating a great need for better pain and distress control during wound care procedures. It is difficult to identify whether pain or distress is the specific primary cause for the high COMFORT-B scores.

Implementation and evaluation of a paediatric nurse-driven sedation protocol in a paediatric intensive care unit

BackgroundOptimal sedation and analgesia is a challenge in paediatric intensive care units (PICU) because of difficulties in scoring systems and specific metabolism inducing tolerance and withdrawal. Excessive sedation is associated with prolonged mechanical ventilation and hospitalisation. Adult and paediatric data suggest that goal-directed sedation algorithms reduce the duration of mechanical ventilation. We implemented a nurse-driven sedation protocol in a PICU and evaluated its impact.MethodsWe conducted a before and after protocol implementation study in a population of children aged 0–18 years who required mechanical ventilation for at least 24 h between January 2013 and March 2015. After the protocol implementation in January 2014, nurses managed analgesia and sedation following an algorithm that included the COMFORT behaviour scale (COMFORT-B). Duration of mechanical ventilation was the primary outcome; secondary outcomes were total doses and duration of medications, PICU length of stay, incidence of ventilator-associated pneumonia, and occurrence of withdrawal symptoms. Pre–post analysis followed with segmented regression analysis of interrupted time series was used to assess the effect of protocol.ResultsA total of 200 children were analysed, including 107 before implementation and 93 children after implementation of the protocol. After implementation of the protocol, the total number of COMFORT-B scores per day of mechanical ventilation significantly increased from 3.9 ± 2.5 times during the pre-implementation period to 6.6 ± 3.5 times during the post-implementation period (p < 10−3). Mean duration of mechanical ventilation tended to be lower in the post-implementation period (8.3 ± 7.3 vs 6.6 ± 5.6 days, p = 0.094), but changes in either the trend per trimester from pre-implementation to post-implementation (p = 0.933) or the immediate change after implementation (p = 0.923) were not significant with segmented regression analysis. No significant change between pre- and post-implementation was shown for total dose of sedatives, withdrawal symptoms, agitation episodes, or unplanned endotracheal extubations.ConclusionsThese results were promising and suggested that implementation of a nurse-driven sedation protocol in a PICU was feasible. Evaluation of sedation and analgesia was better after the protocol implementation; duration of mechanical ventilation and occurrence of withdrawal symptoms tended to be reduced.

Undersedation is a risk factor for the development of subglottic stenosis in intubated children

ObjectiveTo analyze the level of sedation in intubated children as a risk factor for the development of subglottic stenosis. MethodsAll patients between 30 days and 5 years of age who required endotracheal intubation in the pediatric intensive care unit between 2013 and 2014 were included in this prospective study. They were monitored daily and COMFORT-B scores were obtained. Flexible fiber-optic laryngoscopy was performed within eight hours of extubation, and repeated seven to ten days later if the first examination showed moderate to severe laryngeal injuries. If these lesions persisted and/or if the child developed symptoms in the follow-up period, microlaryngoscopy under general anesthesia was performed to evaluate for subglottic stenosis. ResultsThe study included 36 children. Incidence of subglottic stenosis was 11.1%. Children with subglottic stenosis had a higher percentage of COMFORT-B scores between 23 and 30 (undersedated) than those who did not develop subglottic stenosis (15.8% vs. 3.65%, p=0.004). ConclusionChildren who developed subglottic stenosis were less sedated than children who did not develop subglottic stenosis.

Usability and effectiveness of Suprathel\xae in partial thickness burns in children

PurposeEvaluation of usability and effectiveness of Suprathel® in the treatment of partial thickness burns in children.MethodsA prospective, observational study to evaluate adherence of Suprathel® to the wound bed, reepithelialization time, grafting, wound colonization and infection, pain, dressing changes, length of hospital stay (LOS) and scar formation.ResultsTwenty-one children (median age 2.4 years, range 5 months–14 years) with a median total body surface area (TBSA) of 4 % (range 1–18) were included. Median LOS was 10 days (range 3–20). Median outer layer dressing changes was 3 (range 1–14). Suprathel® was only adherent in wounds debrided with Versajet®. Median reepithelialization time was 13 days (range 7–29). Three patients needed a split skin graft. There were 7 (33 %) patients with wound colonization before application of Suprathel®. This increased to 12 (57 %) patients during treatment. One patient developed a wound infection. Median visual analog scale (VAS) scores for background and procedural pain in patients >7 years were 3.2 (range 2–5) and 3.5 (range 2–5), respectively. In younger patients, median background and procedural COMFORT-B scores were 13.8 (range 10–23) and 14.8 (range 13–23, p = 0.03), respectively. Patient and Observer Scar Assessment Scale (POSAS) scores were favorable after 3 and 6 months post burn.ConclusionsSuprathel® provides potential advantages regarding pain and scar formation, but extensive wound debridement is needed to achieve adequate adherence.

The COMFORT behaviour scale detects clinically meaningful effects of analgesic and sedative treatment.

The COMFORT behaviour scale (COMFORT-B scale) is widely used in paediatric intensive care units to assess young children's pain and distress. It is also used to assess the impact of treatment interventions, but little is known on the scale's sensitivity to detect changes between before and after measurements following an intervention. This study explored the sensitivity to change of the COMFORT-B scale. COMFORT-B scores, originally and prospectively collected as part of standard care, were retrieved from the digital patient data management system. We analysed scores obtained in 747 paired observations, i.e., before and after a pharmacological intervention in 180 paediatric intensive care patients between September 2009 and September 2010. The mean scores before and after an intervention were 20.0 [standard deviation (SD) 3.7] and 14.1 (SD 4.7), respectively. Multilevel regression analysis showed a 6-point mean decline after an intervention (p < 0.0001). The magnitude of this decline was not statistically significantly related to number and type of interventions or time between assessments. In almost three-quarters of cases (74%), the COMFORT-B score dropped to below 17 after a pharmacological intervention, indicating good responsiveness. This is the first study demonstrating that the COMFORT-B scale detects treatment-related changes in pain or distress intensity. This implies that COMFORT-B assessments can effectively guide analgesic and sedation treatment in critically ill children.

Pain in young children with burns: Extent, course and influencing factors

Little evidence is available on the extent, course and influencing factors of pain in young children with burns. At present, reliable and valid measurement instruments to assess pain behavior in these children are available, implying that valuable insight into these questions can now be obtained. The aim of this study is to document the extent and course of pain behavior with the COMFORT-B, and to assess factors that may influence procedural pain. First, cutpoints for COMFORT-B scores were established by Rasch analysis to assess clinically relevant changes. Second, the extent of background and procedural pain behavior was assessed by descriptive statistics. Third, the course and factors that may influence procedural pain behavior were investigated by latent growth modeling. Trained nurses collected pain behavior data in 168 children (mean age 20 months, mean TBSA 6%, mean length of stay 10 days). Cutpoints of COMFORT-B scores were as follows: 6–13 (mild pain), 14–20 (moderate pain) and 21–30 (severe pain). This study suggests that background pain is more adequately treated than procedural pain. Factors that influenced baseline pain scores and/or the course over 8 days included TBSA, the number of surgical procedures, acetaminophen administration by the referring hospital, and the application of hydrofiber dressings. The implications of these findings are discussed.

Pharmacokinetics and analgesic effects of intravenous propacetamol vs rectal paracetamol in children after major craniofacial surgery

The pharmacokinetics and analgesic effects of intravenous and rectal paracetamol were compared in nonventilated infants after craniofacial surgery in a double-blind placebo controlled study. During surgery all infants (6 months-2 years) received a rectal loading dose of 40 mg.kg(-1) paracetamol 2 h before anticipated extubation. On admittance to the pediatric surgical ICU, the children were randomized to receive either a 15 min intravenous infusion of 40 mg.kg(-1) propacetamol, a prodrug of paracetamol, or 20 mg.kg(-1) paracetamol rectally every 6 h. A population pharmacokinetic analysis of the paracetamol plasma concentration time-profiles was undertaken using nonlinear mixed effects models. The visual analogue scale (VAS) (score 0-10 cm) and COMFORT Behavior scale (score 6-30) were used to monitor analgesia in the 24-h period following surgery. Twelve infants received intravenous propacetamol and 14 paracetamol suppositories. Paracetamol pharmacokinetics were described according to a two-compartmental model with linear disposition. Pharmacokinetic parameters were standardized to a 70 kg person using allometric '1/4 power' models. Parameter estimates were: absorption half-life from the rectum 4.6 h, propacetamol hydrolysis half-life 0.028 h, clearance 12 l.h(-1).70 kg(-1), intercompartmental clearance 116 l.h(-1).70 kg(-1), central and peripheral volume of distribution 7.9 and 44 l.70 kg(-1), respectively. During the 24-h study period 22 infants exhibited VAS scores <4 cm, which was considered a cutoff point. On single occasions four patients, two in each group, exhibited a VAS score >/=4 cm. Nine patients in the rectal treatment group and three patients in the intravenous treatment group received midazolam for COMFORT-B scores exceeding 17 (P < 0.05). Intravenous propacetamol proved to be more effective than rectal paracetamol in infants after craniofacial surgery. Midazolam was more frequently administered to patients receiving paracetamol suppositories, indicating that these children experienced more distress, possibly caused by pain.

Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT ???behavior??? scale*

The original COMFORT scale, including both observational and physiologic items, has been validated for measuring distress in children admitted to a pediatric intensive care unit. However, physiologic variables are influenced by drugs given in the pediatric intensive care unit setting. The objectives of this study were to assess the usefulness of physiologic variables in judgment of sedation and to determine new cutoff points for the COMFORT "behavioral" scale (COMFORT-B), using only observational items. Prospective observational study. Pediatric intensive care unit in a university hospital. Seventy-eight patients admitted to the pediatric intensive care unit. None. COMFORT scores were obtained in this patient group. Similar to the original COMFORT scale validation, the expert opinion of nurses (Nurse Interpretation Score of Sedation) served to determine optimal cutoff scores for the COMFORT-B scale. A total of 843 combined COMFORT and Nurse Interpretation Score of Sedation scores were obtained in 78 patients. Cronbach's alpha for the COMFORT scale was .78, increasing to .84 when the physiologic items, blood pressure and heart rate, were excluded. COMFORT scores were significantly different for the three Nurse Interpretation Score of Sedation categories (Kruskal-Wallis, p < .001). According to the pediatric intensive care unit nurses, undersedation was present in 11% and oversedation in 3% of all observations. Cutoff points for the COMFORT-B scale were </=10 for oversedation and >/=23 for undersedation. The area in the COMFORT-B score between 11 and 22 does not adequately predict under- or oversedation, pointing to a need for supplemental observation. The COMFORT-B scale is a reliable alternative to the original COMFORT scale. The cutoff points of the COMFORT-B scale in conjunction with the Nurse Interpretation Score of Sedation facilitate the use of sedation algorithms on the pediatric intensive care unit.