Observational Scale Of Behavioral Distress-Revised Research Articles

Comparison of preadministered and coadministered lidocaine for treating pain and distress associated with intranasal midazolam administration in children: A randomized clinical trial.

ObjectivePain and distress associated with intranasal midazolam administration can be decreased by administering lidocaine before intranasal midazolam (preadministered lidocaine) or combining lidocaine with midazolam in a single solution (coadministered lidocaine). We hypothesized coadministered lidocaine is non‐inferior to preadministered lidocaine for decreasing pain and distress associated with intranasal midazolam administration.MethodsRandomized, outcome assessor–blinded, noninferiority trial. Children aged 6 months to 7 years undergoing laceration repair received intranasal midazolam with preadministered or coadministered lidocaine. Pain and distress were evaluated with the Observational Scale of Behavioral Distress—Revised (OSBD‐R) (primary outcome; non‐inferiority margin 1.8 units) and the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Faces, Legs, Activity, Cry, Consolability (FLACC) scales and cry duration (secondary outcomes). Secondary outcomes also included adverse events, clinician and caregiver satisfaction, and pain and distress associated with intranasal lidocaine administration.ResultsFifty‐one patients were analyzed. Mean OSBD‐R scores associated with intranasal midazolam administration were 6.4 (95% confidence interval [CI] 5, 7.8) and 7 (95% CI 5.2, 8.9) units for preadministered and coadministered lidocaine, respectively. The difference of 0.6 (95% CI –1.7, 2.8) units represented an inconclusive non‐inferiority determination. CHEOPS and FLACC scores and cry duration were similar between groups. OSBD‐R, CHEOPS, and FLACC scores and cry duration associated with intranasal lidocaine administration were 3.8, 9.9, and 6 units, and 56 seconds, respectively. Clinicians considered coadministered lidocaine easier to administer.ConclusionPain and distress associated with intranasal midazolam administration were similar when using coadministered or preadministered lidocaine, but our non‐inferiority determination was inconclusive. Administration of intranasal lidocaine by itself was associated with a measurable degree of pain and distress.Keywords: intranasal, midazolam, anxiolysis, sedation, emergency department, emergency medicine, pain, distress, pediatric, lidocaine, laceration

Children Listening to Music or Watching Cartoons During ER Procedures: A RCT.

This study aims to determine if listening to music and watching cartoons are effective to distract children from pain and distress during procedures in the emergency room (ER). This study is a single-center, 3-armed, superiority randomized controlled trial comparing listening to music, watching cartoons, and standard care during ER procedures in children aged 3-13 years. The primary outcome was pain measured from video footage with the Alder Hey Triage Pain Score (AHTPS). Children older than 4 years self-reported pain with the Faces Pain Scale-Revised (FPS-R). The secondary outcome was distress measured with the Observational Scale of Behavioral Distress-revised (OSBD-r). Another indicator of distress was heart rate. Data of 191 participants were analyzed for the 3 groups: music (n = 75), cartoon (n = 62), and control (n = 54). The median age was 7.3 years (4.9-9.7). In multivariable analysis, pain assessed with the AHTPS was significantly lower (B = -1.173, 95% confidence interval -1.953, -0.394, p = .003) in the music group than in the control groups. Across the 3 groups, 108 children self-reported pain with the FPS-R after the procedure. The scores were lowest in the music group, but the differences between groups were not significant (p = .077). OSBD-r distress scores assigned during the procedures were not significantly different between the 3 groups (p = .55). Heart rate directly after the procedure was not statistically significantly different between the 3 groups (p = .83). Listening to recorded music is a beneficial distraction for children experiencing pain during ER procedures, whereas watching cartoons did not seem to reduce pain or distress.

Tablet Computer as a Distraction Tool During Facial Laceration Repair: A Randomized Trial.

Child life interventions reduce the anxiety of medical procedures but are not always available in emergency departments. In this study, we determined the effect of parent-directed tablet computer use without child life direction on patient anxiety and on parent and suturing clinician experience during pediatric facial laceration repair. In a children's hospital emergency department, we enrolled children 2 to 12 years of age undergoing unsedated facial laceration repairs and randomized them to parent-directed tablet computer distraction or standard supportive care. We measured anxiety using the Observational Scale of Behavioral Distress-Revised (OSBD-R) for 5 procedure phases from videotaped laceration repairs. We compared OSBD-R scores for 5 phases and weighted averages between the tablet and standard care groups. Parents and suturing clinicians completed surveys about their experiences after the procedures. From April 2014 to July 2015, 77 patients (39 tablet, 38 standard) underwent repairs. Age, use of restraint, procedure duration, and number of sutures were similar between the 2 groups. The groups did not differ in procedure phase or weighted-average OSBD-R scores. Parents in the tablet group reported less personal anxiety compared with parents in the standard group (P = 0.01). In a post hoc subgroup analysis, subjects in the unrestrained tablet group had lower OSBD-R scores during the anesthetic injection phase than did subjects in the unrestrained standard group (P = 0.04). If restrained, subjects in the tablet group had higher OSBD-R scores during the anesthetic injection phase than did subjects in the standard group (P = 0.048). Unrestrained children may benefit from parent-directed tablet computer distraction. Parents who operate the device are less anxious during their children's procedures.

Randomized Trial of Intranasal Fentanyl Versus Intravenous Morphine for Abscess Incision and Drainage.

Abscess incision and drainage (I&D) are painful and distressing procedures in children. Intranasal (IN) fentanyl is an effective analgesic for reducing symptomatic pain associated with fractures and burns but has not been studied for reducing procedural pain during abscess I&D. Our objective was to compare the analgesic efficacy of IN fentanyl with intravenous (IV) morphine for abscess I&D in children. We performed a randomized noninferiority trial in children aged 4 to 18 years undergoing abscess I&D in a pediatric emergency department. Patients received IN fentanyl (2 μg/kg; maximum, 100 μg) or IV morphine (0.1 mg/kg; maximum, 8 mg). The primary outcome, determined independently by blinded assessors, was the Observational Scale of Behavioral Distress-Revised (OSBD-R). The prestated margin of noninferiority (Δ) was 1.80. Secondary outcomes included self-reported pain, treatment failure, and patient and parental satisfaction. We enrolled 20 children (median age, 15.4 years), 10 in each group. The difference between total OSBD-R scores was -13.45 (95% confidence interval, -24.24 to -2.67), favoring IN fentanyl.There was less self-reported pain in patients who received IN fentanyl immediately after the procedure. Four patients (40%) receiving IV morphine had treatment failures and required moderate sedation or had the procedure terminated. More patients who received IN fentanyl were satisfied with the analgesic administered compared with those who received IV morphine. In a small sample of children aged 4 to 18 years undergoing abscess I&D, IN fentanyl was noninferior, and potentially superior, to IV morphine for reducing procedural pain and distress.

Quantification of Pain and Distress Associated With Intranasal Midazolam Administration in Children and Evaluation of Validity of Four Observational Measures.

The aims of this study were to quantify the pain and distress associated with the administration of intranasal (IN) midazolam in young children using 4 observational measures and to evaluate the degree of validity of these measures. We conducted a prospective observational pilot study. Children aged 1 to 7 years requiring IN midazolam were enrolled. Children were videotaped, and scores were assigned to baseline and administration phases using the Observational Scale of Behavioral Distress-Revised (OSBD-R), Children's Hospital of Eastern Ontario Pain Scale (CHEOPS), and the Faces-Legs-Activity-Cry-Consolability (FLACC) scale. The cry duration following administration was assessed. Interrater reliability and convergent validity were determined for all 4 measures. Internal consistency and responsivity for the OSBD-R, CHEOPS, and FLACC scales were determined. We enrolled 20 children. The mean OSBD-R, CHEOPS, and FLACC scores associated with administration of IN midazolam were 27.1 (SD, 13.5), 11.5 (SD, 1.2), and 8.9 (SD, 2.7), respectively. The mean cry duration was 105.5 (SD, 68.8) seconds. The intraclass correlation coefficients for all measures ranged from 0.82 to 0.99. The Cronbach α's for the OSBD-R, CHEOPS, and FLACC were between 0.71 and 0.97. Pearson correlation coefficients for comparisons between OSBD-R, CHEOPS, and FLACC were between 0.82 and 0.96 but were between 0.32 and 0.51 for comparisons involving cry duration. We have identified estimates of pain and distress associated with administration of IN midazolam in young children that can be used to determine desired effect sizes for trials that study interventions to treat this pain and distress. The OSBD-R, CHEOPS, and FLACC scales are suitable choices for outcome measures.

Can live music therapy reduce distress and pain in children with burns after wound care procedures? A randomized controlled trial

ObjectiveBurn wound care procedures are very painful and lead to distress. Live music therapy has shown beneficial effects on distress and pain in specific pediatric patient populations. In this study we measured whether live music therapy has beneficial effects in terms of less distress and pain in children with burns after wound care procedures. MethodsThis randomized assessor-blinded controlled trial (RCT) took place at the burns unit of the Red Cross War Memorial Children’s Hospital, Cape Town, South Africa. It included newly admitted inpatients between the ages of 0 and 13 years undergoing their first or second wound care procedures. Excluded were children with a hearing impairment or low level of consciousness. The intervention group received one live music therapy session directly after wound care in addition to standard care. The control group received standard care only. The primary outcome was distress measured with the Observational Scale of Behavioral Distress-revised (OSBD-r). The secondary outcome was pain measured with the COMFORT-behavioral scale (COMFORT-B). In addition, in children older than 5 years self-reported distress with the validated Wong-Baker scale (FACES) and pain with the Faces Pain Scale-Revised (FPS-R) were measured. Patients in both groups were videotaped for three minutes before wound care; during the music therapy or the control condition; and for two minutes thereafter. Two researchers, blinded to the study condition, independently scored the OSBD-r and the COMFORT-B from the video footage before and after music therapy. ResultsWe included 135 patients, median age 22.6 months (IQR 15.4–40.7 months). Change scores did not significantly differ between the intervention and the control groups for either distress (p=0.53; d=0.11; 95% CI −0.23 to 0.45) or pain (p=0.99; d=0.04; 95% CI −0.30 to 0.38). Self-reported distress in a small group of children (n=18) older than 5 years indicated a significant reduction in distress after live music therapy (p=0.05). ConclusionsLive music therapy was not found effective in reducing distress and pain in young children after burn wound care. Older children might be more responsive to this intervention.

Developing a medical picture book for reducing venipuncture distress in preschool-aged children.

Distress associated with needle-related procedures is a major concern in preschool-aged children nursing. This study developed a medical picture book for supporting preschool-aged children facing a venipuncture and determined the effectiveness of such a book intervention in decreasing behavioural distress. The picture book was designed in 3 stages: developing stories on medical situations, penning the text, and drafting the book. We conducted a quasiexperimental study to examine the effectiveness of the book. The behavioural distress of the control and picture book groups were assessed before, during, and after the intervention by using the Observational Scale of Behavioral Distress-Revised (OSBD-R). We created a 12-page picture book, Sick Rui-Rui Bear, in which cartoon characters were depicted undergoing venipunctures, as a guide for vein injection and for facilitating positive venipuncture outcomes in preschool-aged children. Over time, the OSBD-R scores of the picture book group were significantly lower than those of the control group (P<.001). We recommend the picture book be routinely read and used during venipunctures to decrease procedural distress in preschool-aged children.

Effect of Playing Interactive Computer Game on Distress of Insulin Injection Among Type 1 Diabetic Children.

Background:Diabetic children and their families experience high level stress because of daily insulin injection.Objectives:This study was conducted to investigate the impact of an interactive computer game on behavioral distress due to insulin injection among diabetic children.Patients and Methods:In this clinical trial, thirty children (3-12 years) with type 1 diabetes who needed daily insulin injection were recruited and allocated randomly into two groups. Children in intervention groups received an interactive computer game and asked to play at home for a week. No special intervention was done for control group. The behavioral distress of groups was assessed before, during and after the intervention by Observational Scale of Behavioral Distress–Revised (OSBD-R).Results:Repeated measure ANOVA test showed no significantly difference of OSBD-R over time for control group (P = 0.08), but this changes is signification in the study group (P = 0.001). Comparison mean score of distress were significantly different between two groups (P = 0.03).Conclusions:According to the findings, playing interactive computer game can decrease behavioral distress induced by insulin injection in type 1 diabetic children. It seems this game can be beneficial to be used alongside other interventions.

Music to Reduce Pain and Distress in the Pediatric Emergency Department

Many medical procedures aimed at helping children cause them pain and distress, which can have long-lasting negative effects. Music is a form of distraction that may alleviate some of the pain and distress experienced by children while undergoing medical procedures. To compare music with standard care to manage pain and distress. Randomized clinical trial conducted in a pediatric emergency department with appropriate sequence generation and adequate allocation concealment from January 1, 2009, to March 31, 2010. Individuals assessing the primary outcome were blind to treatment allocation. A total of 42 children aged 3 to 11 years undergoing intravenous placement were included. Music (recordings selected by a music therapist via ambient speakers) vs standard care. The primary outcome was behavioral distress assessed blinded using the Observational Scale of Behavioral Distress-Revised. The secondary outcomes included child-reported pain, heart rate, parent and health care provider satisfaction, ease of performing the procedure, and parental anxiety. With or without controlling for potential confounders, we found no significant difference in the change in behavioral distress from before the procedure to immediately after the procedure. When children who had no distress during the procedure were removed from the analysis, there was a significantly less increase in distress for the music group (standard care group = 2.2 vs music group = 1.1, P < .05). Pain scores among children in the standard care group increased by 2 points, while they remained the same in the music group (P = .04); the difference was considered clinically important. The pattern of parent satisfaction with the management of children's pain was different between groups, although not statistically significant (P = .07). Health care providers reported that it was easier to perform the procedure for children in the music group (76% very easy) vs the standard care group (38% very easy) (P = .03). Health care providers were more satisfied with the intravenous placement in the music group (86% very satisfied) compared with the standard care group (48%) (P = .02). Music may have a positive impact on pain and distress for children undergoing intravenous placement. Benefits were also observed for the parents and health care providers. clinicaltrials.gov Identifier: NCT00761033.

Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

The objective of this study was to compare the efficacy of 3 doses of intranasal ketamine (INK) for sedation of children from 1 to 7 years old requiring laceration repair. This was a randomized, prospective, double-blind trial of children requiring sedation for laceration repair. Patients with simple lacerations were randomized by age to receive 3, 6, or 9 mg/kg INK. Adequacy and efficacy of sedation were measured with the Ramsay sedation score and the Observational Scale of Behavioral Distress-Revised. Serum ketamine and norketamine levels were drawn during the procedure. Sedation duration and adverse events were recorded. Of the 12 patients enrolled, 3 patients achieved adequate sedation, all at the 9-mg/kg dose. The study was suspended at that time as per predetermined criteria. Nine milligrams of INK per kilogram produced a significantly higher proportion of successful sedations than the 3- and 6-mg/kg doses.

Ketamine/Midazolam Versus Etomidate/Fentanyl

Orthopedic reductions are commonly performed procedures requiring sedation in the pediatric emergency department (PED). Ketamine is a widely used agent for pediatric procedural sedation, but its use may present difficulties in select populations, such as those with psychiatric diagnoses. In such a case, alternative agents that are safe and effective are needed. Etomidate is a commonly used induction agent for rapid-sequence intubation in the PED. Several retrospective and few prospective studies support etomidate's safety and efficacy in pediatric procedural sedation. The objective was to compare etomidate/fentanyl (E/F) with ketamine/midazolam (K/M) for procedural sedation during orthopedic reductions in the PED. Prospective, partially blinded, randomized controlled study comparing intravenously administered K/M with intravenously administered E/F. A convenience sample of patients, aged 5 to 18 years, presenting to an urban PED with fracture requiring reduction was enrolled. Outcome measures included guardian and staff completion of visual analog scale and Likert scales for observed pain and satisfaction, blinded OSBD-r (Observational Scale of Behavioral Distress-Revised) scoring of digital recordings of reductions, and sedation and recovery times. Descriptive tracking of adverse effects, adverse events, and interventions were recorded at the sedation. Twenty-three patients were enrolled, 11 in the K/M group and 12 in the E/F group. The K/M group had significantly lower mean OSBD-r scores compared with the E/F group (0.08 vs 0.89, P = 0.001). Parents rated lower visual analog scale scores with K/M than with E/F (13.7 vs 50.5, P = 0.003) and favored K/M on a 5-point satisfaction scale (P = 0.004). The E/F group had significantly shorter total sedation times (49.6 vs 77.6 minutes, P = 0.003) and recovery times (24.7 vs 61.4 minutes, P = 0.000). There were no significant differences with respect to procedural amnesia and orthopedic practitioner satisfaction. Adverse effects noted in the K/M group included dysphoric emergence reaction and vomiting. Vomiting, injection-site pain, myoclonus, airway readjustment, and supplemental oxygen use were observed in the E/F group. This is a small study that strongly suggests that, for pediatric orthopedic reductions, K/M is more effective at reducing observed distress than E/F, although both provide equal procedural amnesia. With its significantly shorter sedation and recovery times, E/F may be more applicable for procedural sedation for shorter, simpler procedures in the PED.

Assessing Procedural Pain in Children With Cancer in Beirut, Lebanon

This study describes the relationship between different indicators of pain, including self-reports, behavioral observations, and physiological measures, in children with cancer undergoing invasive procedures. Forty-five children between the ages of 4 and 10 years were evaluated while undergoing Port-a-Cath access. The study was conducted in the outpatient clinics of the Children's Cancer Center in Beirut, Lebanon. Children used 2 self-report measures of pain (the Wong-Baker FACES Pain Rating Scale and an adaptation of the FACES, the DOLLS). Parents and nurses assessed the child's pain on the FACES and the child's distress on the Observational Scale of Behavioral Distress-Revised. Nurses recoded behavioral observations as well as physiological responses to pain. There was a high degree of consistency between the self-reports and moderate to high correlations between self-reports, behavioral parameters, and physiological parameters, suggesting that accurate pain assessments can be made by both nurses and parents. The results also demonstrate adequate validity and reliability of the DOLLS scale in a Lebanese population, in addition to being the preferred assessment tool for all the children in the study.

Efficacy and safety of nitrous oxide in alleviating pain and anxiety during painful procedures

AIMSTo evaluate the efficacy and safety of nitrous oxide for children undergoing painful procedures.METHODSNinety children requiring repeated painful procedures (lumbar puncture, bone marrow aspirate, venous cannulation, or dressing changes) were...

A randomized clinical trial of continuous-flow nitrous oxide and midazolam for sedation of young children during laceration repair

Study Objective: To compare the efficacy and complication profile of oral midazolam therapy and continuous-flow 50% nitrous oxide in alleviating anxiety during laceration repair in children 2 to 6 years old. Methods: We conducted a prospective, randomized clinical trial using 4 study groups who required laceration repair: (1) children who received standard care alone, which included comforting and topical anesthesia augmented with injected lidocaine if needed; (2) children who received standard care and oral midazolam; (3) children who received standard care and nitrous oxide; and (4) children who received standard care, oral midazolam, and nitrous oxide. Videotapes were blindly scored using the Observational Scale of Behavioral Distress-Revised (OSBD-R) to assess distress during baseline, wound cleaning, lidocaine injecting, suturing, and recovery. Adverse effects were noted during suturing and by parent questionnaires completed 24 hours after suturing and at suture removal. OSBD-R data were analyzed using repeated-measures analysis of variance. Adverse effect data were analyzed using categorical models. Results: Two hundred four subjects were enrolled (midazolam plus nitrous oxide 52, midazolam 51, nitrous oxide 51, standard care 50; mean patient age was 4.1 years; 66% were boys). Mean OSBD-R scores were lower for groups that received nitrous oxide during wound cleaning by 2.2 points (95% confidence interval [CI] 1.1 to 3.2), lidocaine injecting by 2.5 points (95% CI 1.4 to 3.5), and suturing by 2.9 (95% CI 1.8 to 3.9). Adverse effects occurred more frequently, and recovery times were longer for groups that received midazolam. Conclusion: For facial suturing in 2- to 6-year-old children, regimens including continuous-flow nitrous oxide were more effective in reducing distress, and had fewer adverse effects and shorter recovery times than midazolam. [Luhmann JD, Kennedy RM, Porter FL, Miller JP, Jaffe DM. A randomized clinical trial of continuous-flow nitrous oxide and midazolam for sedation of young children during laceration repair. Ann Emerg Med. January 2001;37:20-27.]