Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children
- Registration Number
- NCT04586504
- Lead Sponsor
- Columbia University
- Brief Summary
Dose-finding study to compare intranasal midazolam doses of 0.2, 0.3, 0.4 and 0.5 mg/kg in children undergoing laceration repair to achieve the following aims:
Specific Aim #1: To determine the most effective dose of intranasal midazolam for producing adequate sedation state associated with each dose.
Specific Aim #2: To determine the time to recovery and describe the adverse events associated with each dose.
- Detailed Description
Intranasal midazolam is a common and effective sedative whose use in children presenting to emergency departments has been described. However, the doses of intranasal midazolam used have varied greatly, with no identified optimal dose. Doses most commonly described in literature reviews, research studies, and clinical guidelines range from 0.2 to 0.5 mg/kg. There is only one study, retrospective, that compares doses and suggests that clinical efficacy is improved with higher doses, without any clear difference in safety. There is a need for a rigorously-conducted trial to determine the dose of intranasal midazolam that optimizes the adequacy of sedation state without leading to adverse events or compromising emergency department-centric outcomes such as time to onset of sedation and time to recovery. To fill this important and persistent gap in knowledge, the investigator will conduct a dose-finding study using an adaptive trial design to compare intranasal midazolam doses of 0.2, 0.3, 0.4, and 0.5 mg/kg in children undergoing laceration repairs, one of the most common types of minor trauma treated in emergency departments.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Ages 6 months to 7 years old (i.e. before their 8th birthday)
- Simple laceration
- Attending physician has decided intranasal midazolam indicated to facilitate repair
- Repair using tissue adhesive (e.g. Dermabond) or staples
- Known or confirmed developmental delay
- Baseline motor neurological abnormality (e.g. motor deficit, cerebral palsy)
- Autism spectrum disorder
- Illness associated with chronic pain
- Known allergy to midazolam or any other benzodiazepine
- Eyelid laceration
- Tongue or intraoral lacerations
- Nasal obstruction that cannot be easily cleared
- Does not speak English or Spanish
- Foster children, wards of the state
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.4 mg/kg Intranasal midazolam Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg. 0.5 mg/kg Intranasal midazolam Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg. 0.3 mg/kg Intranasal midazolam Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg. 0.2 mg/kg Intranasal midazolam Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg.
- Primary Outcome Measures
Name Time Method Pediatric Sedation State Scale Score From study drug administration until procedure finished (approximately 60 minutes) The Pediatric Sedation State Scale (PSSS) is scored from 0 to 5, representing a continuum of sedation that spans from over-sedation associated with changes in vital signs (0) to inadequate sedation (5).
- Secondary Outcome Measures
Name Time Method Time to onset of minimal sedation From study drug administration until procedure finished (approximately 60 minutes) Time (in minutes) from administration of intranasal midazolam until a University of Michigan Sedation State (UMSS) score of 1 is achieved. The UMSS represents a spectrum of depth of sedation ranging from unarousable (4) to awake and alert (0). Note: This outcome was initially listed as a primary outcome, but was changed to a secondary outcome in the IRB-approved protocol and prior to enrollment of the first patient.
Time to recovery From study drug administration until patient discharge (approximately 120 minutes) Time (in minutes) from procedure completion until a Simplified Aldrete Score (SAS) of at least 6 is achieved. The score ranges from 0 (lowest) to 8 (highest). If a patient already fulfills criteria for recovery at procedure start, then time to recovery is 0.
Incidence of adverse events From study drug administration until patient discharge (approximately 120 minutes) Adverse events will be defined using the Pediatric Emergency Research Canada and Pediatric Emergency Care Applied Research Network Consensus-Based Recommendations. These adverse events include oxygen desaturation; apnea (central, obstructive, laryngospasm); clinically apparent pulmonary aspiration; retching/vomiting; bradycardia; hypotension; excitatory movements; paradoxical response to sedation; unpleasant recovery reactions; and permanent complications (including death).
OSBD-R Scale Score From study drug administration until procedure finished (approximately 60 minutes) Procedural pain and distress will be measured using the Observational Scale of Behavioral Distress - Revised (OSBD-R). Each 15-second interval is scored from 0 (no pain or distress) to 23.5 (maximal pain and distress).
UMSS Scale Score From study drug administration until procedure finished (approximately 60 minutes) Depth of sedation will be measured using the University of Michigan Sedation Scale (UMSS). This sedation scale ranges from zero to four with higher numbers indicating deeper sedation.
Trial Locations
- Locations (1)
NewYork Presbyterian Morgan Stanley Children's Hospital
🇺🇸New York, New York, United States