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IN Sub-Dissociative Ketamine vs IN Fentanyl

NCT02521415 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2022-07-26

Study results available
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Summary

This single center, randomized control, double blind trial will prospectively examine the feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for pain control in the pediatric emergency department setting. The investigators hypothesize that IN ketamine may provide a safe and effective alternative to IN fentanyl for children with suspected, isolated extremity fractures.

Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.

Conditions

  • Bone Fracture

Interventions

DRUG

ketamine

intranasal (IN) sub-dissociative ketamine (1mg/kg)

DRUG

fentanyl

Intranasal (IN) fentanyl (1.5 micrograms/kg)

DRUG

ibuprofen or acetaminophen

10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention

Sponsors & Collaborators

  • Carolinas Trauma Network Research Group

    collaborator UNKNOWN

  • Charlotte, Houston, Milwaukee Prehospital Emergency Research Nodal Center-CHaMP-ERNC

    collaborator UNKNOWN

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Stacy Reynolds, MD · Carolinas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-11-30
Completion
2016-11-30

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 NCT02521415 on ClinicalTrials.gov