Actively Recruiting

Phase 3
Age: 6Years - 17Years
All Genders
ID06160778

Intravenous Ketorolac Versus Morphine in Children Presenting With Acute Abdominal Pain and Suspected Appendicitis: A Multi-centre Non-Inferiority Randomized Controlled Trial

Led by University of Calgary · Updated on 2024-06-24

495

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

Sponsors

U

University of Calgary

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying children aged 6 to 17 who come to the emergency department with belly pain suspected to be appendicitis, a common condition requiring surgery. This study aims to compare the pain relief effects of intravenous ketorolac, a non-opioid anti-inflammatory drug, with intravenous morphine, a commonly used opioid. The goal is to see if ketorolac works as well as morphine but with fewer side effects, addressing concerns from the opioid crisis. Participants will be randomly assigned to receive either a single dose of intravenous ketorolac at 0.5 mg/kg (up to 30 mg) or intravenous morphine at 0.1 mg/kg (up to 5 mg). Both treatments are given once, with a matching placebo for the other drug to keep the study blinded. The study is conducted across multiple pediatric emergency departments in Canada, and neither patients nor most medical staff will know which treatment the child receives. During the study, children’s pain will be measured using a verbal numerical rating scale at multiple times after medication administration, including 30, 60, 90, 120 minutes, and up to 6-8 hours. Researchers will also monitor for side effects and the need for additional pain relief. Safety and effectiveness will be carefully assessed, with particular focus on pain reduction and adverse events. The total study participation involves these assessments around the time of treatment.

CONDITIONS

Brief Title

Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 6 and 17 years
  • Abdominal pain lasting 5 days or less
  • Acute abdominal pain being investigated for suspected appendicitis
  • Intravenous (IV) access in place or ordered
  • Currently experiencing moderate to severe abdominal pain with a pain score of 5 or higher on the verbal Numerical Rating Scale
Not Eligible

You will not qualify if you...

  • Previous enrollment in this trial
  • Use of NSAIDs within 3 hours or opioids within 1 to 2 hours prior to enrollment
  • Need for immediate resuscitation or hemodynamic instability
  • Severe cognitive impairment of the child or caregiver preventing study participation
  • Chronic pain requiring daily analgesics
  • History of severe gastrointestinal bleeding or related serious gastrointestinal conditions
  • History of chronic and active interstitial kidney or liver disease
  • Known or suspected pregnancy or breastfeeding
  • Known allergy to NSAIDs or opioids
  • Absence of a parent or guardian for children under 16 years unless a mature minor
  • Inability to obtain consent due to language barriers without available translation services

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment

Treatment

Duration - Up to 8 hours following drug administration

Participants receive a single intravenous dose of either ketorolac or morphine and are monitored for pain relief and adverse events.

1 treatment visit with assessments at multiple time points within 8 hours

Trial Site Locations

Total: 1 location

1

Alberta Children's Hospital Emergency Department

Calgary, Alberta, Canada, T3B 6A8

Actively Recruiting

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Research Team

M

Mohamed M Eltorki, MBChB, MSc

A

Angela Wallace

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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