Anxiolysis for Laceration Repair in Children

NCT05383495 | Recruiting Phase 3 DMC

• 1 other identifier: DFS05081977
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Observational Scale of Behavioral Distress - Revised (OSBD-R)

  Score ranges from 0 (no distress) to 23.5 (maximal distress) and will be scored for the time interval encompassing preparation and suturing

  During preparation, suturing, and recovery (20 minutes)

Secondary Outcomes (4)

• Adverse effects

  From intervention to 72 hours post-discharge

• Need for additional anxiolysis or sedation to facilitate repair

  During suturing (10 minutes)

• Need for physical restraint

  During preparation and suturing (10 minutes)

• Late maladaptive behaviors

  From discharge to 72 hours post-discharge

Other Outcomes (13)

• Compliance with intervention administration

  From drug administration through completion of suturing (40 minutes)

• Caregiver satisfaction with anxiolysis during laceration repair

  At discharge (1 minute)

• Child satisfaction with anxiolysis during laceration repair

  At discharge (1 minute)

Study Arms (3)

Intranasal dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Intranasal midazolam

EXPERIMENTAL

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

Drug: Midazolam Nasal Spray

Inhaled nitrous oxide

EXPERIMENTAL

50% N2O in 50% oxygen by face mask or on-demand system

Drug: Nitrous oxide

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Intranasal dexmedetomidine

Midazolam Nasal Spray DRUG

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

Also known as: Versed

Intranasal midazolam

Nitrous oxide DRUG

50% nitrous oxide in 50% oxygen by face mask

Also known as: Nitronox

Inhaled nitrous oxide

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• i) Age 2-12.99 years \[highest incidence of laceration repair\] ii) Single or grouped lacerations separated by no more than 2 cm for which the treating physician believes repair does not require IV sedation iii) Repair to involve sutures and performed by ED physician or designate (trainee) iv) Child or caregiver desires anxiolysis for laceration repair \[justification: incorporates family preferences based on their prior experiences or beliefs about child's response\] vii) Local anesthesia planned to involve topical anesthetic (LET), infiltrated lidocaine, ring, or thenar block

You may not qualify if:

• i) Sedative, anxiolytic, or alpha-2-adrenergic receptor agonist \< 24 hours prior to interventions (may compound sedative effect and increase the SAE risk). 24-hours encompasses the duration of sedation of most agents.
• ii) Hypersensitivity to any intervention iii) Occlusion of \> 1 nostril due to polyps, septal deviation, or foreign body (may prevent drug absorption) iv) Hemodynamic abnormalities: bradycardia or hypotension \< 2 SD of age-related normal value v) IND contraindications: Pre-existing renal insufficiency, uncorrected mineralocorticoid deficiency, pulmonary hypertension, uncorrected cyanotic heart disease, cardiac conduction disorder, pulmonary hypertension, pulmonary edema, vitamin B12 or folate disorder, phenylketonuria, or psychosis vi) Sedation contraindications: Impaired level of consciousness or respiratory instability vii) N2O contraindications: Conditions associated with potential accumulation of gas within body spaces viii) Suspected or confirmed pregnancy (as reported by patient) ix) Inability to vocalize pain due to motor deficits (unable to apply the OSBD-R) x) Caregiver unable to complete study tasks due to insufficient comprehension of either English or French in the absence of a native language interpreter xi) Weight \>= 65 kg (to avoid under-dosing of INM or IND) x) Not American Society of Anesthesiologists class I (healthy) or II (controlled mild to moderate disease) xii) No concomitant fracture or dislocation requiring orthopedic manipulation

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, N6A 5W9, Canada

RECRUITING

Related Publications (2)

• Jiang A, Poonai N, Arthur-Hayward V, Heath A. Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE). Trials. 2025 Aug 7;26(1):280. doi: 10.1186/s13063-025-09009-z.

  PMID: 40775649 DERIVED

• Poonai N, Arthur-Hayward V, Ali S, Sabhaney V, Doan Q, Trottier E, Gravel J, Tran NA, Bhatt M, Eltorki M, Thull-Freedman J, Leung J, Beer D, Jiang A, Poolacherla R, Heath A. Anxiolysis for laceration repair in children: study protocol for an open-label multicenter adaptive trial (ALICE). PLoS One. 2025 Jun 4;20(6):e0324515. doi: 10.1371/journal.pone.0324515. eCollection 2025.

  PMID: 40465577 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Midazolam; Nitrous Oxide; Entonox

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Central Study Contacts

Naveen Poonai, MD

CONTACT

5196858500; naveen.poonai@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase III, multicentre, open-label, randomized, three-arm, adaptive trial

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 20, 2022
• Study Start: December 19, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)