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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04586504
Other study ID # AAAS7996
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date September 8, 2021
Est. completion date May 14, 2024

Study information

Verified date May 2024
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 and time to onset of minimal sedation associated with each dose. Specific Aim #2: To determine the time to recovery and describe the adverse events associated with each dose.


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 information / eligibility

Status Completed
Enrollment 101
Est. completion date May 14, 2024
Est. primary completion date May 14, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months to 7 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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


Related Conditions & MeSH terms


Intervention

Drug:
Intranasal midazolam
5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.

Locations

Country Name City State
United States NewYork Presbyterian Morgan Stanley Children's Hospital New York New York

Sponsors (3)

Lead Sponsor Collaborator
Columbia University Emergency Medicine Foundation, Mailman School of Public Health

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bhatt M, Kennedy RM, Osmond MH, Krauss B, McAllister JD, Ansermino JM, Evered LM, Roback MG; Consensus Panel on Sedation Research of Pediatric Emergency Research Canada (PERC) and the Pediatric Emergency Care Applied Research Network (PECARN). Consensus-based recommendations for standardizing terminology and reporting adverse events for emergency department procedural sedation and analgesia in children. Ann Emerg Med. 2009 Apr;53(4):426-435.e4. doi: 10.1016/j.annemergmed.2008.09.030. Epub 2008 Nov 20. — View Citation

Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation State Scale. Pediatrics. 2017 May;139(5):e20162897. doi: 10.1542/peds.2016-2897. — View Citation

Elliott CH, Jay SM, Woody P. An observation scale for measuring children's distress during medical procedures. J Pediatr Psychol. 1987 Dec;12(4):543-51. doi: 10.1093/jpepsy/12.4.543. No abstract available. — View Citation

Leu C-S, Levin B. On the probability of correct selection in the Levin-Robbins sequential elimination procedure. Stat Sin 1999;9(3):879-91.

Malviya S, Voepel-Lewis T, Tait AR, Merkel S, Tremper K, Naughton N. Depth of sedation in children undergoing computed tomography: validity and reliability of the University of Michigan Sedation Scale (UMSS). Br J Anaesth. 2002 Feb;88(2):241-5. doi: 10.1093/bja/88.2.241. — View Citation

Mellion SA, Bourne D, Brou L, Brent A, Adelgais K, Galinkin J, Wathen J. Evaluating Clinical Effectiveness and Pharmacokinetic Profile of Atomized Intranasal Midazolam in Children Undergoing Laceration Repair. J Emerg Med. 2017 Sep;53(3):397-404. doi: 10.1016/j.jemermed.2017.05.029. — View Citation

Tsze DS, Ieni M, Fenster DB, Babineau J, Kriger J, Levin B, Dayan PS. Optimal Volume of Administration of Intranasal Midazolam in Children: A Randomized Clinical Trial. Ann Emerg Med. 2017 May;69(5):600-609. doi: 10.1016/j.annemergmed.2016.08.450. Epub 2016 Nov 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pediatric Sedation State Scale Score 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). From study drug administration until procedure finished (approximately 60 minutes)
Primary Time to onset of minimal sedation 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). From study drug administration until procedure finished (approximately 60 minutes)
Secondary Time to recovery 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. From study drug administration until patient discharge (approximately 120 minutes)
Secondary Incidence of adverse events 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). From study drug administration until patient discharge (approximately 120 minutes)
Secondary OSBD-R Scale Score 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). From study drug administration until procedure finished (approximately 60 minutes)
Secondary UMSS Scale Score 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. From study drug administration until procedure finished (approximately 60 minutes)
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