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IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair

NCT03528512 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-08-24

Study results available
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Summary

Often, repair of the cuts (laceration repair) proves to be traumatic for the children and the parents. Nasal spray (Intranasal/IN) approaches for procedural pain reduction, such as during dental work, have been demonstrated to make drug administration painless and well tolerated. We are comparing IN ketamine to IN midazolam and fentanyl for pain and reducing anxiety during repair of cuts in children.

Conditions

  • Laceration of Skin

Interventions

DRUG

Ketamine

Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)

DRUG

Midazolam and fentanyl

Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)

Sponsors & Collaborators

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • Kelly Levasseur, DO · William Beaumont Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2019-02-06
Completion
2019-02-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03528512 on ClinicalTrials.gov