Sublingual Midazolam Research Articles

Pre Medication With Midazolam in Children For Smooth Separation From Parents: A Comparison Of Two Different Routes of Administration

Premedication with midazolam is widely used in paediatric anaesthesia to reduce fear, anxiety, emotion, psychological trauma and ensure smooth separation from parents. However, various routes and dosing regimens are recommended for paediatric premedication and variable efficacy is found when use in different routes. The aim of our study to compare the efficacy and acceptable route between intranasal versus sublingual midazolam premedication for smooth separation from parents before entering the operation theater. It will be a comparative, cross-sectional prospective clinical study. 120 unmedicated children, ASA I or II, Age 1–6 years, who will be scheduled for routine elective surgery and who will be planned to receive midazolam as a premedicant drug, will be randomly assigned to one of the two groups. Group–I receives intranasal midazolam 0.2 mg kg-1 and Group–II receives sublingual midazolam 0.2 mg kg-1 after having obtained the parent’s informed consent. Heart rate, Systolic blood pressure, SpO2, Sedation and Anxiolysis Scores will be assessed in 4-point scale by the anaesthesiologist every 3 min prior to surgery. Sixty patients will be enrolled in each group, I and II. Data will be compiled and analyzed in computer, using statistical software package SPSS.
 JCMCTA 2016 ; 27 (2) : 24 - 30

Sublingual plus oral midazolam without intravenous access to complement topical anesthesia for phacoemulsification surgery

Sublingual plus oral midazolam without intravenous access to complement topical anesthesia for phacoemulsification surgery

Comparison of Behavior and Dental Anxiety During Intranasal and Sublingual Midazolam Sedation – A Randomized Controlled Trial

The objective of the study was to assess the behavioral effects and the changes in the anxiety level of children after intranasal and sublingual midazolam sedation using Venham's clinical anxiety scale and salivary cortisol level. Twenty children aged 3 to 7 years were randomly assigned to Group A (n=10) intranasal or Group B (n=10) sublingual midazolam (0.2mg/kg) sedation. The anxiety levels at various time periods were assessed using Venham clinical anxiety scale and corresponding changes in salivary cortisol levels were assessed before and after the drug administration. The anxiety levels were assessed independently by two pediatric dentists from recorded videos. Wilcoxon signed rank test and Mann Whitney U test were used for statistical analysis using SPSS version 19.0. There was a significant decrease in anxiety level from baseline to 20 minutes after drug administration in group A (p=0.004) and group B (p=0.003). There was no significant change in salivary cortisol levels before and after the drug administration in group A (p=0.07) and group B (p=0.38). Both intranasal and sublingual administration of midazolam was equally effective in reducing the child's anxiety. However, there was no significant difference in the salivary cortisol levels in both groups.

Premedication with midazolam is equally effective via the sublingual and intravenous route of administration

Background. The aim of this study was to investigate the clinical efficacy and potential side effects of sublingual midazolam, used for premedication, in comparison with intravenous midazolam. The second aim was to explore cost-effectiveness of sublingual midazolam administration.Methods. A prospective, randomized, controlled, single-blinded trial was conducted at the Clinical Hospital Centre Osijek, Croatia, during the period 1st of May till 31st of October, 2012. We enrolled 140 patients (American Society of Anesthesio-logists (ASA) physical status I-II, age≥18 years) scheduled for some kind of elective surgical procedure. Exclusion criteria were ASA III or higher, psychiatric disorders, allergy to midazolam and use of psychotropic drugs. Patients were randomi-zed into one of two groups. One group received 2.5 mg of midazolam intravenously and the other group received 1/4 of a midazolam tablet (approximately 3.75 mg) sublingually. Sedation was clinically evaluated using the Ramsey sedation scale at 0, 10, 20 and 30 minutes after drug administration. We also noted side effects and degree of amnesia.Results. Ten minutes after administration of premedication, a significantly higher number of patients in the intravenous group had a Ramsey score of 2 (p=0.000). Ten and twenty minutes after drug administration, most of the patients in the sublingual group had a Ramsey score 1-2, and after 30 minutes most of them had a Ramsey score 2-3, which is comparable with the intravenous (p=0.642) group. Conclusion. Sublingual application of midazolam has an equivalent sedative effect as intravenous midazolam 20 minutes after administration but is associated with a bitter taste and weaker amnestic effect.

Comparison of a morphine and midazolam combination with morphine alone for paediatric displaced fractures: a randomized study

To compare the efficacy of sublingual midazolam with oral morphine versus that of oral morphine with placebo in a paediatric population attending an emergency department (ED) with acute long-bone fractures. A sample of children aged 5-16 years with clinically deformed closed long-bone fractures was randomized to groups receiving either oral morphine (0.5 mg/kg)/sublingual placebo or oral morphine (0.5 mg/kg)/sublingual midazolam (0.2 mg/kg). The main exclusion criteria were narcotic or benzodiazepine use, significant head injury, multiple organ failure, femoral fracture and allergy. Pain scores were rated on a 100-mm visual analogue scale (VAS) at 0, 15, 30, 60, 90 and 120 min. Fifty-eight children were enrolled (mean age: 10.5 years, SD 2.7). Fractures concerned the radius or ulna in 43 cases (74.1%), the humerus (22.4%) and the tibia or fibula (3.5%). No significant difference in VAS scores was observed between the two treatment arms (p = 0.72). Drowsiness was significantly more frequent in the midazolam group (p = 0.007) during the first 2 h after administration. No serious adverse event was observed. The analgesic performances of morphine and the combination of morphine with midazolam assessed by VAS were similar in children presenting at the ED with a long-bone fracture.

Is premedication with midazolam more effective by the sublingual than the oral route?

Background:In this study, we compared the sedative effects of sublingual midazolam solution with the oral tablet as premedication. Sixty pediatric patients of ASA physical status I and II were randomly selected to receive either 0.5 mg/kg of tablet or 0.5 mg/kg of sublingual solution of midazolam as premedication, about 45 min before elective surgery.Materials and Methods:There were 30 patients in each group. In Group I, the patients received premedication in the form of oral midazolam tablet 0.5 mg/kg. In Group II, the patients received midazolam solution 0.5 mg/kg. The degree of sedation and ease of separation was assessed according to the Niall C. Wilton scale and the procedure of Davis Peter, respectively. The time for complete drug dissolution was noted in both the groups. Then, the patients were interviewed regarding their acceptance of taste.Results:The sedation scores in the sublingual group were higher than in the oral group at 30 and 45 min after drug administration (P=0.0134 and P=0.0157). 66.6% of the patients in the sublingual group found it satisfactory as compared to 53.3% in the case of group receiving tablet.Conclusion:Thus, from the present study, it is concluded that premedication with midazolam is more effective by the sublingual than the oral route in children.

Evaluation Of Sedation Characteristics With Intranasal Midazolam Versus Sublingual Midazolam In Paediatric Patients Undergoing Magnetic Resonance Imaging

BACKGROUND ;-The purpose of this comparative study was to compare prospectively the sedation characteristics of intranasal midazolam to sublingual midazolam in paediatric patients up to 10 years undergoingmagnetic resonance imaging (MRI).METHODS ixty paediatric patients referred for body MRI were divided equally to one of two treatment group. The 30 patients of group I received 0.3 mg/kg intranasal midazolam spray in to each nostril 15 min before MRI whereas the 30 patients of group II received 0.3mg/kg sublingual Midazolam 15 min before MRI. The patients responses to drug administration, onset of sedation time (parent child separation time) were noted. Heart rate, oxygen saturation, respiratory rate and degree of sedation by Ramsay scale of sedation were recorded before procedure and at 2min and up to 30 min after the drug is given to the patient. Recovery score as per Aldrete criteria were also noted. Image quality was evaluated on a 4 point scale. RESULTS :In group I, 30/30 MRI examination [100%], were completed successfully without relevant adverse effect. In group II, 05/30 patients for MRI examination [07%] ,reduction of anxiety and sedation were insufficient and low dose I.V. Propofol 0.75mg/kg supplement was given. MRI sedation quality was rated higher among patients of group I compared to group II [p<0.05] which affected the better imaging quality as well. CONCLUSION ;Therapeutic intranasal midazolam spray is an effective to overcome anxiety and provide better sedation than sublingual route in paediatric patient undergoing MRI and doses used in our study are optimum without any side effects.

Premedication with Sublingual Morphine Sulphate in Abdominal Surgery

Treatment with analgesics before surgery may be effective in reducing post-operative pain. This approach is defined as "pre-emptive analgesia" and recent reviews show conflicting results. The aim of this study was to investigate the efficacy of pre-emptive analgesia with sublingual morphine sulphate, compared with sublingual midazolam in patients undergoing elective abdominal surgery. Prior to surgery, 29 patients were randomized and premedicated with sublingual morphine sulphate 0.5 mg/kg (Group A; n = 15) or with sublingual midazolam 0.03 mg/kg (Group B; n = 14). General anaesthesia was maintained with sevoflurane and fentanyl. Post-operatively, intravenous (IV) acetaminophen 0.02 mg/kg was given to all patients and a bolus of IV morphine 0.1 mg/kg was given to Group B patients. Post-operative pain was controlled by IV morphine via a patient-controlled analgesia (PCA) device. IV acetaminophen 0.02 mg/kg was also administered four times daily. Efficacy was assessed using static Visual Analogue Scale (sVAS) scores, dynamic VAS (dVAS) scores, number of PCA doses administered and number of failed doses registered from the PCA device at 4, 6, 24 and 48 hours after surgery. Results were statistically analysed using the Student t-test; a value of p < 0.05 was considered significant. Significantly lower sVAS and dVAS scores were observed in Group A patients than in Group B at all assessment periods (p < 0.05 for all time points). There were less PCA administered and failed doses in Group A, compared with Group B (all time points p < 0.05). There was no difference in the occurrence of common side effects between the two treatments. In patients undergoing elective abdominal surgery, premedication with sublingual morphine sulphate results in a better control of post-operative pain, compared to premedication with sublingual midazolam. The beneficial effect of pre-operative sublingual morphine sulphate was apparent in the immediate post-operative period and was sustained over the 48-hour assessment period.

Comparison of the Intramuscular, Intranasal or Sublingual Routes of Midazolam Administration for the Control of Soman‐Induced Seizures*

This study evaluated the anticonvulsant effectiveness of midazolam to stop seizures elicited by the nerve agent soman when midazolam was administered by different routes (intramuscular, intranasal or sublingual) at one of two different times after the onset of seizure activity. Guinea pigs previously prepared with cortical electrodes to record brain electroencephalographic activity were pre-treated with pyridostigmine (0.026 mg/kg, intramuscularly) 30 min. before challenge with a seizure-inducing dose of the nerve agent soman (56 microg/kg, subcutaneously), and 1 min. later, they were administered 2.0 mg/kg atropine sulfate admixed with 25.0 mg/kg 2-PAM Cl (intramuscularly). Groups of animals were administered differing doses of midazolam by the intramuscular, intranasal or sublingual route at either the onset of seizure activity or 40 min. after the onset of seizure activity that was detected in the electroencephalographic record. When given immediately after seizure onset, the anticonvulsant ED50 of intramuscular midazolam was significantly lower than that of intranasal midazolam, which in turn was significantly lower than sublingual midazolam at that time. At the 40-min. treatment delay, the anticonvulsant ED50s of intramuscular or intranasal midazolam did not differ and both were significantly lower than the sublingual route. Higher doses of midazolam were required to stop seizures at the 40-min. treatment delay time compared to immediate treatment. The speed of seizure control for intramuscular or intranasal midazolam was the same while sublingual midazolam acted significantly slower. Midazolam was effective in treating soman-induced seizures when given by all three routes, but with differences in potency and speed of action.

Sedative Effect of Sublingual Midazolam after Oral Chloral Hydrate or Hydroxyzine in Children

Sedative Effect of Sublingual Midazolam after Oral Chloral Hydrate or Hydroxyzine in Children

Premedication with melatonin: a double-blind, placebo-controlled comparison with midazolam

We have evaluated the perioperative effects of melatonin with those of midazolam in 75 women in a prospective, randomized, double-blind, placebo-controlled study. Patients were given sublingual midazolam 15 mg, melatonin 5 mg or placebo, approximately 100 min before a standard anaesthetic. Sedation, anxiety and orientation were quantified before, and 10, 30, 60 and 90 min after premedication, and 15, 30, 60 and 90 min after admission to the recovery room. Psychomotor performance was evaluated at these times also, using the digit-symbol substitution test (DSST) and the Trieger dot test (TDT). Patients who received premedication with either midazolam or melatonin had a significant decrease in anxiety levels and increase in levels of sedation before operation compared with controls. Midazolam produced the highest scores for sedation at 30 and 60 min after administration and significant psychomotor impairment in the preoperative period compared with melatonin or placebo. After operation, patients who received midazolam or melatonin premedication had increased levels of sedation at 30 min and impairment in performance on the DSST at 15, 30 and 90 min compared with controls. There were no significant differences between the three groups for anxiety levels or TDT performance after operation. Amnesia was notable only in the midazolam group for one preoperative event (entry into the operating room). Patient satisfaction was noted in the midazolam and melatonin groups only. We have demonstrated that melatonin can be used effectively for premedication of adult patients.

120 Intranasal or sublingual midazolam for treating acute seizures in children at home

120 Intranasal or sublingual midazolam for treating acute seizures in children at home

Premedication with Midazolam Is More Effective by the Sublingual than Oral Route

This study compared the sedative effects of sublingual tablet midazolam (Roche Dormicum 7.5 mg) with the oral route as premedication. One hundred ASA physical status I and II gynaecological patients were randomly selected to receive a 7.5 mg tablet of midazolam either sublingually or orally as premedication about one hour before elective surgery. There were 50 patients in each group. The degree of sedation was assessed according to the Ramsay scale initially and then at 20. 30, 45 and 60 min intervals by a second observer blinded to the route of administration. The time for complete drug dissolution was studied in the sublingual group by the inspection of tablet residue under the tongue every five minutes for 20 min, then the patients were interviewed regarding their acceptance of the taste. The sedation scores in the sublingual group were higher than in the oral group at 30 and 60 min after drug administration. (P=0.0054 and P=0.008) Seventy-two percent of the sublingual group had complete drug dissolution within 10 min and 64% of the patients in the sublingual group found the tablet acceptable with regard to its taste. Midazolam 7.5 mg sublingual is a more effective pre-anaesthetic sedative than by the oral route.

Comparison of Intranasal and Sublingual Midazolam as a Preanesthetic Medication in Pediatric Patients

Comparison of Intranasal and Sublingual Midazolam as a Preanesthetic Medication in Pediatric Patients