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Alpha-2 Adrenergic Agonist

Intranasal Dexmedetomidine Dose-finding Study

Phase 2
Waitlist Available
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up index visit
Awards & highlights
No Placebo-Only Group

Summary

The most common injury prompting an emergency department (ED) visit in children is a cut (laceration) that requires repair using stitches or skin glue. Despite anesthetic (freezing), laceration repair is often very distressful because in young children, most occur on the face. There is currently no effective drug to relieve the distress of laceration repair in children. The goal is to find a safe and effective drug to reduce distress in children undergoing laceration repair. Dexmedetomidine is a new drug that safely provides mild sedation and can be given as a painless nasal spray. Intranasal dexmedetomidine (IND) has been shown to reduce distress in children undergoing painful procedures such as dental work and intravenous insertion. However, no large study has explored IND for laceration repair. In order for research to change the way we care for children, a large study that enrolls children across many paediatric EDs needs to be performed. The first step is to conduct a smaller study to identify the safest and most effective dose. The proposed study plans to enroll 55 children age 1-10 years who require laceration repair.

Eligible Conditions
  • Stitches

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~index visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and index visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adequate sedation
Secondary study objectives
Adverse effects
Anxiolysis
Compliance
+7 more

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Dexmedetomidine 1 mcg/kgExperimental Treatment1 Intervention
Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 1 mcg/kg (max 100 mcg or 1 mL).
Group II: Dexmedetomidine 2 mcg/kgActive Control1 Intervention
Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 2 mcg/kg (max 100 mcg or 1 mL).
Group III: Dexmedetomidine 4 mcg/kgActive Control1 Intervention
Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 4 mcg/kg (max 100 mcg or 1 mL).
Group IV: Dexmedetomidine 3 mcg/kgActive Control1 Intervention
Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 3 mcg/kg (max 100 mcg or 1 mL).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
2015
Completed Phase 4
~2050

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
681 Previous Clinical Trials
431,285 Total Patients Enrolled
~10 spots leftby Dec 2025