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Ketorolac for Moderate to Severe Abdominal Pain in Children

NCT04528563 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-02-28

No results posted yet for this study

Summary

In children and adolescents (older than 6 years in age) who arrive in the pediatric emergency department because they have been having 5 days or less of abdominal pain (possible appendicitis), will patients who are treated with ketorolac get just as much pain relief as those patients treated with morphine?

To answer this research question, we will need a large number of patients in a study. To ensure we have enough patients, we must include many hospitals in different cities and provinces in the same study. Before doing this, though, we must first test a smaller version of the study in our center at McMaster Children's hosptial. The goal of doing this at McMaster first is to make sure or understand:

1. We can enroll enough people in our study over 1 year
2. We can make sure that all the information we collect from patients is complete and nothing is missing
3. Reasons behind why people don't want to participate in the study
4. How satisfied patients and their caregivers were with the study

Conditions

Interventions

DRUG

Ketorolac Tromethamine 10 MG/ML

Non-Steroidal-Anti-Inflammatory given intravenously.

DRUG

Morphine Sulfate 10Mg/1mL Injection

Opioid commonly used for acute abdominal pain given intravenously.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Mohamed Eltorki, MBChB · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2023-02-05
Completion
2023-02-06

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT04528563 on ClinicalTrials.gov