Intranasal Dexmedetomidine Dose-finding Study

NCT03957304 | Completed Phase 2 DMC

• 1 other identifier: 51384
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laceration Repair

Outcome Measures

Primary Outcomes (1)

• Adequate sedation

  The number of participants with adequate sedation defined as a PSSS or 2 or 3 for the duration of the measurement period (initial positioning to tying of the last suture)

  Index visit

Secondary Outcomes (10)

• Onset of sedation

  Index visit

• Adverse effects

  Index visit

• Anxiolysis

  Index visit

• Compliance

  Index visit

• Satisfaction with laceration repair: 5-item Likert scale

  Index visit

Study Arms (4)

Dexmedetomidine 1 mcg/kg

EXPERIMENTAL

Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 1 mcg/kg (max 100 mcg or 1 mL).

Drug: Dexmedetomidine

Dexmedetomidine 2 mcg/kg

ACTIVE COMPARATOR

Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 2 mcg/kg (max 100 mcg or 1 mL).

Drug: Dexmedetomidine

Dexmedetomidine 3 mcg/kg

ACTIVE COMPARATOR

Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 3 mcg/kg (max 100 mcg or 1 mL).

Drug: Dexmedetomidine

Dexmedetomidine 4 mcg/kg

ACTIVE COMPARATOR

Intranasal dexmedetomidine 100 mcg/mL (Precedex, Pfizer) 4 mcg/kg (max 100 mcg or 1 mL).

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Intranasal dexmedetomidine

Dexmedetomidine 1 mcg/kg; Dexmedetomidine 2 mcg/kg; Dexmedetomidine 3 mcg/kg; Dexmedetomidine 4 mcg/kg

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children age 1-10 years who present to the ED with an isolated laceration \< 5 cm
• deemed to require suture repair based on the opinion of the treating physician
• predicted to resist positioning for laceration repair based on the opinion of the caregiver

You may not qualify if:

• laceration repair requiring procedural sedation (without IND) or local nerve block, - other injuries requiring reduction (fracture or dislocation) or repair (nailbed injury or laceration)
• lacerations containing foreign body material (including dirt and debris)
• history of hypersensitivity to dexmedetomidine
• occlusion of at least one nare due to mucus, polyps, septal deviation, etc.
• concomitant use of an alpha 2-adrenergic receptor agonist
• bradycardia or hypotension for age (possible transient but clinically insignificant adverse effects of dexmedetomidine)

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Related Publications (1)

• Poonai N, Sabhaney V, Ali S, Stevens H, Bhatt M, Trottier ED, Brahmbhatt S, Coriolano K, Chapman A, Evans N, Mace C, Creene C, Meulendyks S, Heath A. Optimal Dose of Intranasal Dexmedetomidine for Laceration Repair in Children: A Phase II Dose-Ranging Study. Ann Emerg Med. 2023 Aug;82(2):179-190. doi: 10.1016/j.annemergmed.2023.01.023. Epub 2023 Mar 3.

  PMID: 36870890 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of dose levels will not be possible so outcome assessors will be blinded by virtue of being remote from the clinical encounter. Furthermore, video segments will commence immediately after intranasal sprays are given so outcome assessors will not see what volume is administered. Two independent assessors will score each video and an interrater agreement (kappa) will be calculated.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dose-escalation pilot study

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: February 20, 2020
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: April 7, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)