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Anxiolysis for Laceration Repair in Children

NCT05383495 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-04-30

No results posted yet for this study

Summary

This is a 3-arm adaptive clinical trial to the optimal light sedative for reducing distress during laceration repair in children. The investigators will compare intranasal (IN) dexmedetomidine, IN midazolam, and nitrous oxide (N20). The primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R).

Conditions

  • Laceration of Skin
  • Distress, Emotional

Interventions

DRUG

Dexmedetomidine

Intranasal dexmedetomidine 3 mcg/kg \[100 mcg/mL (max 200 mcg or 2 mL)

DRUG

Midazolam Nasal Spray

Intranasal midazolam 0.4 mg/kg \[5 mg/mL (max 10 mg or 2 mL)

DRUG

Nitrous oxide

50% nitrous oxide in 50% oxygen by face mask

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05383495 on ClinicalTrials.gov