← Back to Search

Alpha-2 Adrenergic Agonist

Sedatives for Anxiety with Lacerations in Children (ALICE Trial)

Phase 3

Recruiting

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 from drug administration to discharge (80 minutes)

Awards & highlights

ALICE Trial Summary

This trial compares 3 sedatives to see which is best for reducing distress in kids getting stitches. Primary outcome is the OSBD-R.

Who is the study for?

This trial is for children aged 2 to nearly 13 years who need stitches for a single cut and don't require heavy sedation. The child or caregiver must want mild sedation, which will be given alongside local anesthesia. Kids with certain heart rates or blood pressure issues, suspected pregnancy, inability to express pain, language barriers without an interpreter, over 65 kg in weight, not healthy or with controlled disease only (ASA class I/II), drug allergies or recent sedatives can't join.Check my eligibility

What is being tested?

The study tests three light sedatives: dexmedetomidine and midazolam as nasal sprays, and nitrous oxide gas. It aims to find the best one for calming kids during stitch application after cuts. Children are randomly assigned to receive one of these treatments and their distress levels are measured using the OSBD-R scale.See study design

What are the potential side effects?

Possible side effects include sleepiness, slower heart rate from dexmedetomidine; drowsiness or mood changes from midazolam; nausea or dizziness from nitrous oxide. Each medication has specific risks that depend on individual health conditions.

ALICE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from drug administration to discharge (80 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from drug administration to discharge (80 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from drug administration to discharge (80 minutes) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Adverse effects

Late maladaptive behaviors

Need for additional anxiolysis or sedation to facilitate repair

+1 more

Other outcome measures

Caregiver satisfaction with anxiolysis during laceration repair

Caregiver state anxiety

Child satisfaction with anxiolysis during laceration repair

+10 more

ALICE Trial Design

3Treatment groups

Experimental Treatment

Group I: Intranasal midazolamExperimental Treatment1 Intervention

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

Group II: Intranasal dexmedetomidineExperimental Treatment1 Intervention

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

Group III: Inhaled nitrous oxideExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexmedetomidine

2015

Completed Phase 4

~1980

Nitrous oxide

2007

Completed Phase 4

~990

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

659 Previous Clinical Trials

413,432 Total Patients Enrolled

Media Library

Dexmedetomidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05383495 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial have an age restriction, and if so, is it feasible for individuals over 70 years old to participate?

"The only individuals that meet the criteria for this trial are aged between two and twelve years old. In comparison, there are 10 studies recruiting patients under 18 and 41 trials enrolling those over 65."

Answered by AI

How many participants are being incorporated into this clinical trial?

"Correct. The clinical trial registry reveals that this experiment, which was initially launched on August 15th 2023, is actively recruiting participants. 300 people need to be enrolled from 1 centre."

Answered by AI

Has the Food and Drug Administration approved Intranasal dexmedetomidine for therapeutic use?

"Based on the existing data, our team concluded that intranasal dexmedetomidine is relatively safe and awarded it a score of 3. This decision was based on multiple rounds of efficacy testing as well as safety assessments."

Answered by AI

Is enrollment to this experiment still available?

"Affirmative. Information on clinicaltrials.gov confirms this medical study, which was first made available on August 15th 2023, is actively recruiting patients for participation. The team needs to enlist 300 people from a single site."

Answered by AI

Who has the necessary qualifications to join in this medical study?

"This medical trial is recruiting 300 children aged between two and twelve with skin lacerations. Qualifying individuals must also meet additional criteria, such as a maximum weight of 65 kilograms to ensure adequate dosing, not having any concomitant fractures or dislocations, expressed desire for anxiolysis in the repair process, planned administration of local anesthesia through topical LET or infiltrated lidocaine, and American Society of Anesthesiologists Class I (healthy) or II (mild-moderate systemic disease that is medically well-controlled)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Anxiolysis for Laceration Repair in Children

2023. "Anxiolysis for Laceration Repair in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05383495.