Safety and efficacy of chloral hydrate for procedural sedation in paediatric ophthalmology: a systematic review and meta-analysis

Mataftsi, Asimina; Malamaki, Paraskevi; Prousali, Efthymia; Riga, Paraskevi; Lathyris, Dimitrios; Chalvatzis, Nikolaos; Haidich, Anna‐Bettina

doi:10.1136/bjophthalmol-2016-309449

Cited by 17 publications

(14 citation statements)

References 38 publications

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“…The systematic review showed that the midazolam oral solution had a lower sedation success rate than chloral hydrate, consistent with the results of the previous systematic review (Mataftsi et al, 2017), but the evidence quality was low, and the chloral hydrate group dose was higher than the regular clinical dose. The overall incidence of adverse effects was comparable.…”

Section: Summary Of Main Findingssupporting

confidence: 85%

“…The UK Formulary recommends taking 0.5 mg/kg of midazolam (maximum dose 20 mg) orally in children 30-60 min before the test (Committee P F., 2017). Seven related systematic reviews were identified (Peng et al, 2014;Sun et al, 2014;Zhang et al, 2014;Guo, 2015;Pasin et al, 2015;Jun et al, 2017;Mataftsi et al, 2017). Midazolam has a lower success rate of sedative hypnosis compared to chloral hydrate, but there is no statistical difference in safety, and the quality of included studies is poor (Mataftsi et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

“…Seven related systematic reviews were identified (Peng et al, 2014;Sun et al, 2014;Zhang et al, 2014;Guo, 2015;Pasin et al, 2015;Jun et al, 2017;Mataftsi et al, 2017). Midazolam has a lower success rate of sedative hypnosis compared to chloral hydrate, but there is no statistical difference in safety, and the quality of included studies is poor (Mataftsi et al, 2017). Dexmedetomidine is better than midazolam in children separated from parents in pre-anesthesia induction (Peng et al, 2014;Sun et al, 2014;Zhang et al, 2014;Guo, 2015;Pasin et al, 2015;Jun et al, 2017).…”

Section: Introductionmentioning

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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Section: Summary Of Main Findingssupporting

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

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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“…Highly stimulating procedures (e.g., EEG, magnetic resonance imaging, auditory brainstem response) and less stimulating procedures (e.g., computed tomography scan, echocardiogram, and physical exam) would not all be expected to have the same success rate when using an orally administered sedation medication. 16,17 In addition, chloral hydrate is well known for its poor taste and it requires a large volume for sedation (500 mg/5 mL or 250 mg/5 mL), thus causing difficulty in dose administration. Variable gastric absorption also results in unpredictable onset of action and difficulty in ensuring adequate sedation.…”

Section: Discussionmentioning

confidence: 99%

Is Orally Administered Pentobarbital a Safe and Effective Alternative to Chloral Hydrate for Pediatric Procedural Sedation?

Anderson¹,

Dalabih²,

Birisi³

et al. 2018

The Journal of Pediatric Pharmacology and Therapeutics

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OBJECTIVES Chloral hydrate had been extensively used for children undergoing sedation for imaging studies, but after the manufacturer discontinued production, pediatric sedation providers explored alternative sedation medications. Those medications needed to be at least as safe and as effective as chloral hydrate. In this study, we examined if pentobarbital is a suitable replacement for chloral hydrate. METHODS Subjects who received pentobarbital were recruited from a prospectively collected database, whereas we used a retrospective chart review to study subjects who received chloral hydrate. Sedation success was defined as the ability to provide adequate sedation using a single medication. We included electively performed sedations for subjects aged 2 months to 3 years who received either pentobarbital or chloral hydrate orally. We excluded subjects stratified as American Academy of Anesthesiologists category III or higher and those who received sedation for electroencephalogram. The data collected captured subject demographics and complications. RESULTS Five hundred thirty-four subjects were included in the final analysis, 368 in the chloral hydrate group and 166 in the pentobarbital group. Subjects who received pentobarbital had a statistically significant higher success rate [136 (82%) vs 238 (65%), p < 0.001], but longer sleeping time (18.1% vs 0%, p < 0.001) in all age groups. Subjects who received chloral hydrate had a higher risk of airway complications in the <1 year of age group (6.5% vs 1.8%, p = 0.03). CONCLUSIONS For pediatric patients younger than 3 years of age undergoing sedation for imaging studies, oral pentobarbital may be at least as effective and as safe as chloral hydrate, making it an acceptable and practical alternative.

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“…The most common adverse effects of chloral hydrate are a paradoxical reaction to sedation, vomiting and respiratory depression. 8 Concerns have been raised about the potential carcinogenic, neurotoxic and neuroapoptotic effects of chloral hydrate, especially when treating children who are younger than three years of age. 9,10 Dexmedetomidine is a novel drug with anxiolytic, sedative and analgesic effects, and it has been shown to diminish the need for other pain medication during medical procedures.…”

mentioning

confidence: 99%

Systematic review and meta‐analysis found that intranasal dexmedetomidine was a safe and effective sedative drug during paediatric procedural sedation

et al. 2020

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Aim This systematic review and meta‐analysis evaluated the effectiveness of intranasal dexmedetomidine as a sole sedative during paediatric procedural sedation outside the operating room. Methods Relevant literature identified by PubMed, Scopus, ClinicalTrials.gov, ScienceDirect and Cochrane Library up to 31 December 2019 was systematically reviewed. Randomised controlled trials that compared intranasal dexmedetomidine with another sedative or placebo during paediatric procedural sedation were included. Trials that studied intranasal dexmedetomidine as a premedication before anaesthesia were excluded. The primary outcome was the success of the planned procedure. Results We analysed seven randomised controlled trials of 730 patients: four trials with 570 patients compared dexmedetomidine with chloral hydrate and three trials with 160 patients compared dexmedetomidine with midazolam. The incidence of successfully completing the procedure did not differ between dexmedetomidine and chloral hydrate, but dexmedetomidine had a higher success rate than midazolam. The incidence of hypotension, bradycardia or respiratory complications did not differ between the sedatives used. Nausea and vomiting were more common in children treated with chloral hydrate than in those treated with other sedatives. Conclusion Intranasal dexmedetomidine was a safe and effective sedative for minor paediatric procedures.

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Safety and efficacy of chloral hydrate for procedural sedation in paediatric ophthalmology: a systematic review and meta-analysis

Cited by 17 publications

References 38 publications

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

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

Is Orally Administered Pentobarbital a Safe and Effective Alternative to Chloral Hydrate for Pediatric Procedural Sedation?

Systematic review and meta‐analysis found that intranasal dexmedetomidine was a safe and effective sedative drug during paediatric procedural sedation

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