Oral pentobarbital suspension for children sedation during MR imaging

Schlatter, Joël; Kabiche, Sofiane; Sellier, N.; Fontan, Jean-Eudes

doi:10.1016/j.pharma.2018.03.002

Cited by 11 publications

(9 citation statements)

References 12 publications

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“…We followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) (Shamseer et al 2015) and registered this review prospectively with PROSPERO (CRD42016041925). Both authors independently searched MEDLINE, CENTRAL and Embase in July 2017 and again in November 2018 using the key words ‘sedation’, ‘intranasal dexmedetomidine’, ‘children’ and ‘paediatrics’.…”

Section: Methodsmentioning

confidence: 99%

Intranasal dexmedetomidine for sedation in children; a review

Lewis¹,

Bailey

2019

Journal of Perioperative Practice

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Dexmedetomidine is an α2 adrenoreceptor agonist that may be administered by the intranasal route as a sole sedative agent in children. It is odourless, colourless and tasteless and is formulated in a concentration of 100µg.ml−1. We performed a review of published randomised controlled trials in order to determine the efficacy of intranasal dexmedetomidine for sedation in children. Fourteen trials were eligible for inclusion in the review and contained a total of 1809 patients ranging in age from one month to 14 years. Intranasal dexmedetomidine was administered in a dose range of 1–4µg.kg−1 and was compared with various other sedatives. Dexmedetomidine was administered by either drops or a mucosal atomiser device. The procedures ranged from non-painful examinations such as magnetic resonance imaging scans and transthoracic echocardiography to painful procedures such as dentistry and venous cannulation. Administration of 2µg.kg−1 appears to be the optimal dose.

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Section: Methodsmentioning

confidence: 99%

Intranasal dexmedetomidine for sedation in children; a review

Lewis¹,

Bailey

2019

Journal of Perioperative Practice

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“…The oral dose of 4-8 mg/kg and IV dose of 2-3 mg/kg (to a maximum 5-8 mg/kg) are required to achieve deep sedation. The sedation success rates of pentobarbital for MRI in children are 87.8%-99.5% for IV administration [16,17,[26][27][28] and 67%-99.7% for oral administration [26,[29][30][31] with a trend towards increasing failure rates with increasing age and weight. Retrospective comparison analysis found that oral pentobarbital has comparable sedation success rate (99.5% vs. 99.7%) and time to discharge and a lower rate of desaturation (0.2% vs. 0.9%) compared with IV pentobarbital in 2,164 infants undergoing CT or MRI [26].…”

Section: ) Pentobarbitalmentioning

confidence: 99%

Drug selection for sedation and general anesthesia in children undergoing ambulatory magnetic resonance imaging

Jung

2020

Yeungnam Univ J Med

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The prevalence of magnetic resonance imaging (MRI) for diagnosing and monitoring a wide range of disease in children continues to expand with the efficacy benefit of providing high-resolution images of tissue anatomy and quantitative function and the safety advantage of a lack of ionizing radiation [1,2]. Aspects of MRI scans such as loud noises, confined bore of the magnet, and the required immobility to prevent motion artifacts are the causes of anxiety and barriers to successful performance of the procedure in children younger than 6 years and those at any age with development delay, claustrophobia, or involuntary movements or con-The demand for drug-induced sedation for magnetic resonance imaging (MRI) scans have substantially increased in response to increases in MRI utilization and growing interest in anxiety in children. Understanding the pharmacologic options for deep sedation and general anesthesia in an MRI environment is essential to achieve immobility for the successful completion of the procedure and ensure rapid and safe discharge of children undergoing ambulatory MRI. For painless diagnostic MRI, a single sedative/anesthetic agent without analgesia is safer than a combination of multiple sedatives. The traditional drugs, such as chloral hydrate, pentobarbital, midazolam, and ketamine, are still used due to the ease of administration despite low sedation success rate, prolonged recovery, and significant adverse events. Currently, dexmedetomidine, with respiratory drive preservation, and propofol, with high effectiveness and rapid recovery, are preferred for children undergoing ambulatory MRI. General anesthesia using propofol or sevoflurane can also provide predictable rapid time to readiness and scan times in infants or children with comorbidities. The selection of appropriate drugs as well as sufficient monitoring equipment are vital for effective and safe sedation and anesthesia for ambulatory pediatric MRI.

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“…In this pediatric use, it has been provided clinical safety and effectiveness when administering orally or intravenously. 7,9,11 As the human injectable form of pentobarbital is marketed only in the United States and the veterinary injectable form of drug is available in France, extemporaneous oral liquid forms of pentobarbital are prepared by European hospital pharmacists. 11,12 Oral rectal pentobarbital has high bioavailability (>95%) with onset of sedation ranging from 20 to 30 minutes and a duration of sedation ranging from 60 to 90 minutes.…”

Section: Introductionmentioning

confidence: 99%

“…7,9,11 As the human injectable form of pentobarbital is marketed only in the United States and the veterinary injectable form of drug is available in France, extemporaneous oral liquid forms of pentobarbital are prepared by European hospital pharmacists. 11,12 Oral rectal pentobarbital has high bioavailability (>95%) with onset of sedation ranging from 20 to 30 minutes and a duration of sedation ranging from 60 to 90 minutes. 4 The time from administration to discharge is longer than with intravenous (IV) pentobarbital, but adverse events are uncommon, <1% for both respiratory and behavioral issues.…”

Section: Introductionmentioning

confidence: 99%

“…4 However, the drug has an extremely unpleasant taste requiring cooperation during oral administration and sometimes causing rejects of the drug. 11 The rectal route, not giving rise to taste issues and enabling fast onset, seems much more appropriate for imaging sedation procedures. Pentobarbital formulation for rectal administration is not yet available.…”

Section: Introductionmentioning

confidence: 99%

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Stability of Pentobarbital Hydrogel for Rectal Administration in Pediatric Procedural Sedation

et al. 2020

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Purpose: Pentobarbital is a sedative agent to limit children motion during computed tomography or magnetic resonance imaging (MRI) and ensures the successful completion of the imaging procedure. However, data on rectal drug formulation and its stability in practice are not available. The aim of this study was to formulate and evaluate the stability of a ready-to-use rectal pentobarbital gel. Methods: The formulation consisted of a hydrated gel containing 25 mg/mL of pentobarbital sodium, packaged in 10-mL amber glass bottles and stored at either 22°C to 25°C or 2°C to 8°C. At each predetermined time point, samples were taken for visual inspection, pH measurement, and analysis by a validated stability-indicating high-performance liquid chromatography (HPLC) method. The viscosity parameters of the hydrogel formulation were assessed. Results: The freshly prepared rectal formulations appeared clear, colorless, and particular-free with pH readings of 9.75 to 9.83. Over the 90 days of the study period, there was no significant change in appearance or pH values for all stability samples. The HPLC results confirmed the chemical stability when stored at 2°C to 8°C or at 22°C to 25°C. Conclusion: Pentobarbital hydrogel 25 mg/mL are stable chemically at least 90 days and can be administered to children for an effective and fast sedation.

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Oral pentobarbital suspension for children sedation during MR imaging

Cited by 11 publications

References 12 publications

Intranasal dexmedetomidine for sedation in children; a review

Intranasal dexmedetomidine for sedation in children; a review

Drug selection for sedation and general anesthesia in children undergoing ambulatory magnetic resonance imaging

Stability of Pentobarbital Hydrogel for Rectal Administration in Pediatric Procedural Sedation

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