Benzodiazepine Withdrawal Reaction in Two Children following Discontinuation of Sedation with Midazolam

Engelen, B.G.M. van; Gimbrère, J.S.F.; Booy, L. H. D.

doi:10.1177/106002809302700509

Cited by 49 publications

(22 citation statements)

References 8 publications

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“…These are usually attributed to excessive dosages or withdrawal of the drug [8]. However, in older subjects, paradoxical CNS stimulation has been reported to occur, albeit rarely, and ranges from an increased incidence of nightmares, euphoria and rest lessness to hallucinations and hypomanie be havior [9].…”

Section: Discussionmentioning

confidence: 99%

Myoclonus Associated with Lorazepam Therapy in Very-Low-Birth-Weight Infants

1994

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Lorazepam is being used with increasing frequency as a sedative in the newborn and the young infant. Concern has been raised with regard to the safety of lorazepam in this age group, especially in very-low-birth-weight (VLBW; < 1,500 g) infants. Three young infants, all of birth weight < 1,500 g, experienced myoclonus following the intravenous administration of lorazepam. The potential neurotoxic effects of the drug (and its vehicle) in this population are discussed. Injectable lorazepam should be used with caution in VLBW infants.

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Section: Discussionmentioning

confidence: 99%

Myoclonus Associated with Lorazepam Therapy in Very-Low-Birth-Weight Infants

1994

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“…Thirty-four studies from 33 publications were eligible for inclusion and provided usable data [6], [19], [20], [21], [22], [23], [24], [25], [26], [27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38], [39], [40], [41], [42], [43], [44], [45], [46], [47], [48], [49], [50](See Figure 1). …”

Section: Resultsmentioning

confidence: 99%

“…Six case series [44], [45], [47], [48], [49] and 4 single case reports [41], [42], [43], [46] were identified for midazolam. Only two of the children described in all the case reports received midazolam without concomitant opiate sedative therapy [47], [48].…”

Section: Resultsmentioning

confidence: 99%

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The Role of Systematic Reviews in Pharmacovigilance Planning and Clinical Trials Authorisation Application: Example from the SLEEPS Trial

et al. 2013

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BackgroundAdequate sedation is crucial to the management of children requiring assisted ventilation on Paediatric Intensive Care Units (PICU). The evidence-base of randomised controlled trials (RCTs) in this area is small and a trial was planned to compare midazolam and clonidine, two sedatives widely used within PICUs neither of which being licensed for that use. The application to obtain a Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) required a dossier summarising the safety profiles of each drug and the pharmacovigilance plan for the trial needed to be determined by this information. A systematic review was undertaken to identify reports relating to the safety of each drug.Methodology/Principal FindingsThe Summary of Product Characteristics (SmPC) were obtained for each sedative. The MHRA were requested to provide reports relating to the use of each drug as a sedative in children under the age of 16. Medline was searched to identify RCTs, controlled clinical trials, observational studies, case reports and series. 288 abstracts were identified for midazolam and 16 for clonidine with full texts obtained for 80 and 6 articles respectively. Thirty-three studies provided data for midazolam and two for clonidine. The majority of data has come from observational studies and case reports. The MHRA provided details of 10 and 3 reports of suspected adverse drug reactions.Conclusions/SignificanceNo adverse reactions were identified in addition to those specified within the SmPC for the licensed use of the drugs. Based on this information and the wide spread use of both sedatives in routine practice the pharmacovigilance plan was restricted to adverse reactions. The Clinical Trials Authorisation was granted based on the data presented in the SmPC and the pharmacovigilance plan within the clinical trial protocol restricting collection and reporting to adverse reactions.

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“…Such weaning may be a gradual reduction in daily drug dosage with frequent reassessment to ensure that the patient is free of pain and withdrawal symptoms or it may be a change to longer acting oral medications, such as methadone, that can be tapered (81,(83)(84)(85). The starting dose of methadone should be calculated to provide a dose equivalent to the dose of opioid that the neonate is receiving.…”

Section: Opioidsmentioning

confidence: 99%

Prevention and Management of Pain and Stress in the Neonate

Blackmon¹,

Kanto²,

Macdonald³

et al. 2000

Pediatrics

294

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This statement is intended for health care professionals caring for neonates (preterm to 1 month of age). The objectives of this statement are to: 1. Increase awareness that neonates experience pain;2. Provide a physiological basis for neonatal pain and stress assessment and management by health care professionals;3. Make recommendations for reduced exposure of the neonate to noxious stimuli and to minimize associated adverse outcomes; and4. Recommend effective and safe interventions that relieve pain and stress.

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Benzodiazepine Withdrawal Reaction in Two Children following Discontinuation of Sedation with Midazolam

Abstract: Midazolam withdrawal reactions in adults and children, particularly in an intensive care unit, can be significant. Considerable caution must be taken with relatively long-term administration and abrupt discontinuation of midazolam.

Cited by 49 publications

References 8 publications

Myoclonus Associated with Lorazepam Therapy in Very-Low-Birth-Weight Infants

Myoclonus Associated with Lorazepam Therapy in Very-Low-Birth-Weight Infants

The Role of Systematic Reviews in Pharmacovigilance Planning and Clinical Trials Authorisation Application: Example from the SLEEPS Trial

Prevention and Management of Pain and Stress in the Neonate

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