Efficacy of midazolam as oral premedication in children in comparison to triclofos sodium

Radhika, K; Sreejit, Melveetil S; Ramadas, Konnanath Thekkethil

doi:10.4103/0019-5049.183389

Cited by 11 publications

(7 citation statements)

References 19 publications

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“…Midazolam has been established as an effective oral premedication in children. [ 1 2 3 ] In doses of 0.5 mg/kg, it has been found to offer adequate sedation at separation and induction. It does not prolong recovery from anaesthesia or discharge from day care procedures.…”

Section: Discussionmentioning

confidence: 99%

“…Midazolam is the most common oral premedication in children and is reportedly safe and effective both at separation and induction of anaesthesia. [ 1 2 3 ] Nasal premedication with midazolam and dexmedetomidine has been studied as alternatives to oral premedication with comparable results. [ 4 ] Dexmedetomidine is a selective alpha-2 adrenoceptor agonist with sedative and analgesic effects.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy of intranasal dexmedetomidine versus oral midazolam for paediatric premedication

Kumar

Panikkaveetil

et al. 2017

Indian J Anaesth

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Background and Aims:Premedication is an integral component of paediatric anaesthesia which, when optimal, allows comfortable separation of the child from the parent for induction and conduct of anaesthesia. Midazolam has been accepted as a safe and effective oral premedicant. Dexmedetomidine is a selective alpha-2 agonist with sedative and analgesic effects, which is effective through the transmucosal route. We compared the efficacy and safety of standard premedication with oral midazolam versus intranasal dexmedetomidine as premedication in children undergoing elective lower abdominal surgery.Methods:This was a prospective randomised double-blinded trial comparing the effects of premedication with 0.5 mg/kg oral midazolam versus 1 μg/kg intranasal dexmedetomidine in children between 2 and 12 years undergoing abdominal surgery. Sedation scores at separation and induction were the primary outcome measures. Behaviour scores and haemodynamic changes were secondary outcomes. Student's t-test and Chi-square were used for analysis of the variables.Results:Sedation scores were superior in Group B (dexmedetomidine) than Group A (midazolam) at separation and induction (P < 0.001). The behaviour scores at separation, induction and wake up scores at extubation were similar between the two groups. The heart rate and blood pressure showed significant differences at 15, 30 and 45 min in Group B but did not require pharmacological intervention for correction.Conclusion:Intranasal dexmedetomidine at a dose of 1 μg/kg produced superior sedation scores at separation and induction but normal behavioural scores in comparison to oral midazolam in paediatric patients.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Efficacy of intranasal dexmedetomidine versus oral midazolam for paediatric premedication

Kumar

Panikkaveetil

et al. 2017

Indian J Anaesth

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“…One RCT (Radhika et al, 2016), with 60 children included, was about comparing midazolam oral solution with triclofos. The RCT showed that the oral solution of midazolam was more successful [RR = 1.56, 95% CI (1.14, 2.12), P < 0.01].…”

Section: Success Rate Of Sedation and Hypnosismentioning

confidence: 99%

“…One RCT (Radhika et al, 2016) compared midazolam oral solution with triclofos, including 60 children, and showed no significant difference [RR = 1.0, 95% CI (0.91, 1.10), P > 0.05].…”

Section: Success Rate Of Parental Separationmentioning

confidence: 99%

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Efficacy and Safety of Midazolam Oral Solution for Sedative Hypnosis and Anti-anxiety in Children: A Systematic Review and Meta-Analysis

et al. 2020

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Background: Midazolam is recommended by health guidelines for sedation and hypnosis in children. Oral solution is a suitable dosage form for children. But there is no conclusive evidence for sedative-hypnosis and antianxiety effects by midazolam oral solution in children.Methods: Relevant studies were identified through searching PubMed, Embase, Cochrane Library, CINAHL, International Pharmaceuticals, four Chinese electronic databases, and relevant lists. Two reviewers independently selected trials, assessed trial quality, and extracted the data.Results: Eighty-nine randomized controlled trials (RCTs) comparing midazolam oral solution with placebo or blank (n = 33), dexmedetomidine (n = 15), ketamine (n = 11), different midazolam doses (n = 10), midazolam injection (n = 8), chloral hydrate (n = 7), diazepam (n = 5), N 2 O (n = 5), triclofos (n = 4), butorphanol (n = 2), fentanyl (n = 2), hydroxyzine (n = 1), and thiopental (n = 1) were identified. Meta-analysis showed no significant difference in the success rate and duration of sedation and hypnosis between midazolam oral and injectable solution (P > 0.05). The success rate of sedation and hypnosis of midazolam was higher than that of ketamine [risk ratio (RR) = 1.32, 95% CI (1.07, 1.62), I 2 = 0%, P < 0.01]. No significant difference was found in the success rate of sedation and hypnosis, mask acceptance, and parental separation between midazolam oral solution and dexmedetomidine (P > 0.05), and the result of one cohort study was consistent. The results of RCTs and a prospective cohort study showed that the incidence of adverse drug reactions (ADR) was 19.57% (189/966). Incidence of adverse reactions between dose groups of (0.25, 0.5] and (0.5, 1.0] mg/kg was similar [Pf (95% CI) = 0.10 (0.04, 0.24) and Pf (95% CI) = 0.09 (0.02, 0.39), respectively], higher than that of the dose group of (0, 0.25] mg/kg [Pf (95% CI) = 0.01 (0.00, 0.19)].Cheng et al. Efficacy and Safety of Midazolam Oral SolutionConclusions: Available evidence suggests that midazolam oral solution is as good as midazolam injection and dexmedetomidine and is better than ketamine. Based on efficacy and safety results, an oral midazolam solution dose of 0.5-1 mg/kg is recommended for children.

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Prospective, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial comparing the safety and efficacy of intranasal dexmedetomidine to oral midazolam as premedication for propofol sedation in pediatric patients undergoing magnetic resonance imaging: the MIDEX MRI trial

Wabelo,

Schmartz,

Giancursio

et al. 2023

Trials

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Background Children under 6 years who need magnetic resonance imaging usually require sedation to obtain best quality images, but the optimal sedation protocol remains to be determined. In 2018, we showed a 22% interruption in image acquisition during magnetic resonance imaging when performing a propofol-based sedation using a bolus approach. As non-pharmacological premedication is often insufficient to reduce the anxiety of children related to parental separation, pharmacological premedication may be useful to facilitate the induction of anesthesia. In our institution, effective premedication is obtained oral intake of midazolam, though its administration relies on patients’ compliance and could also lead to paradoxical reaction. Dexmedetomidine has a safe profile in the pediatric population and can therefore represent an interesting alternative. The primary objective of this trial is to demonstrate the superiority of intranasal dexmedetomidine compared to oral midazolam as premedication in reducing the occurrence of any event requiring temporary or definitive interruption of the examination to allow anesthesiologist intervention in children undergoing magnetic resonance imaging under propofol sedation. Methods In this single-center, prospective, randomized, double-blind, double-dummy, active comparator-controlled, superiority trial, we planned to include 250 patients, aged 6 months to 6 years, undergoing a scheduled magnetic resonance imaging requiring the presence of an anesthesiologist. After informed consent, the patients will be randomized to receive either oral midazolam or intranasal dexmedetomidine as premedication. The data will be analyzed in intention to treat, using Kolmogorov–Smirnov Z, chi-square, Wilcoxon, and Mann–Whitney U tests. A P-value < 0.05 will be considered statistically significant. Discussion The MIDEX MRI study will assess the efficacy of intranasal dexmedetomidine compared to oral midazolam to improve the quality of a propofol-based sedation prior to magnetic resonance imaging, without negative repercussion on the postoperative period. Trial registration ClinicalTrial.gov NCT05192629. Registered on 14 January 2022. Protocol version 2.1

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Efficacy of midazolam as oral premedication in children in comparison to triclofos sodium

Cited by 11 publications

References 19 publications

Efficacy of intranasal dexmedetomidine versus oral midazolam for paediatric premedication

Efficacy of intranasal dexmedetomidine versus oral midazolam for paediatric premedication

Efficacy and Safety of Midazolam Oral Solution for Sedative Hypnosis and Anti-anxiety in Children: A Systematic Review and Meta-Analysis

Prospective, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial comparing the safety and efficacy of intranasal dexmedetomidine to oral midazolam as premedication for propofol sedation in pediatric patients undergoing magnetic resonance imaging: the MIDEX MRI trial

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