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Intranasal Ketamine for Procedural Sedation

NCT02828566 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2017-08-29

No results posted yet for this study

Summary

This study will examine the effectiveness of intranasal (IN) ketamine compared to standard intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the paediatric population. The aim is to assess if IN administration is equivalent to the current standard of care, IV. The population to be studied is children 4-17 years of age who require a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty in masking interventions, each participant will receive both IV and IN interventions, only one of which will be the real drug. Procedural sedation and analgesia (PSA) will be assessed using the Dartmouth Operative Conditions Scale (DOCS).

Conditions

  • Bone Fractures
  • Dislocations

Interventions

DRUG

IN ketamine

Intranasal ketamine 100 mg/mL solution (10 mg/kg, maximum 800 mg)

DRUG

IV ketamine

Intravenous ketamine 50 mg/mL solution (1 to 1.5 mg/kg, maximum 120 mg)

DRUG

IN saline 0.9%

Intranasal 0.9% normal saline

DRUG

IV saline 0.9%

Intravenous 0.9% normal saline

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Naveen Poonai, MD · Western University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2019-01-31
Completion
2019-02-28
FDA Drug
Yes

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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 NCT02828566 on ClinicalTrials.gov