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A RCT of a Combination of Analgesics for Pain Management in Children With a Suspected Fracture

NCT02985177 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-11-23

No results posted yet for this study

Summary

MSK-I is the most common cause for ED visits for children with pain, with a child's risk of sustaining a fracture ranging from 27-42% by the age of 16 years. MSK-I is known to generate moderate to severe pain in most children and the ED serves as the critical entry point for these injured children. This study aims to provide rapid and sustained pain management for children presenting with a MSK-I in the ED. The investigators will compare the efficacy of two possible medication combinations of fentanyl intranasal (1.0 mcg/kg) + oral ibuprofen (10 mg/kg) and fentanyl intranasal (2.0 mcg/kg) + oral ibuprofen (10 mg/kg) for the rapid, adequate and sustained pain management of children with suspected fracture.

The investigators believe that the combination of different dosage of intranasal fentanyl with ibuprofen will lead to better pain treatment by providing a consistent and adequate level of analgesia throughout the entire ED visit, including prior to physician exam and during painful radiologic procedures.

Conditions

  • Emergency Service, Hospital
  • Child/Adolescent Problem
  • Acute Pain
  • Fentanyl
  • Ibuprofen
  • Analgesics, Opioid
  • Anti-inflammatory Agents, Non-steroidal

Interventions

DRUG

INF2.0 + IBU

Analgesics

DRUG

INF1.0 + IBU

Analgesics

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Le May Sylvie, PhD · St. Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2021-07-31
Completion
2021-09-30

Countries

  • Canada

Study Locations

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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 NCT02985177 on ClinicalTrials.gov