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Published on: November 11, 2014
Intravenous ketorolac versus morphine in children presenting with suspected appendicitis: a pilot single-centre
Mohamed Eltorki1, Jason W Busse2,3, Stephen B Freedman4
1Pediatrics, McMaster University, Faculty of Health Sciences, Hamilton, Ontario, Canada eltorkim@mcmaster.ca.
Insights
This pilot trial assesses the feasibility of comparing ketorolac with morphine for acute abdominal pain in children. The study aims for a 40% consent rate to support a larger trial on pediatric pain management.
Area of Science:
- Pediatric Emergency Medicine
- Clinical Pharmacology
- Pain Management
Background:
- Opioids are commonly prescribed for acute abdominal pain in children despite risks and lack of evidence for superiority over non-steroidal anti-inflammatory drugs (NSAIDs).
- Ketorolac, an NSAID, presents a potentially safer alternative for managing moderate to severe acute abdominal pain in pediatric populations.
- There is a need for evidence-based guidelines on optimal analgesic strategies for acute abdominal pain in children, particularly those with suspected appendicitis.
Purpose of the Study:
- To evaluate the feasibility of conducting a definitive randomized controlled trial (RCT) comparing intravenous ketorolac with intravenous morphine for acute abdominal pain in children.
- To determine the recruitment rate and consent rate as primary feasibility outcomes for a larger, multicenter definitive trial.
- To establish the safety and tolerability of ketorolac and morphine in this pediatric population.
Main Methods:
- A single-center, double-dummy, blinded, randomized controlled trial involving 100 children aged 6-17 years with moderate to severe abdominal pain investigated for appendicitis.
- Participants were randomized 1:1 to receive either IV ketorolac plus IV morphine placebo or IV morphine plus IV ketorolac placebo.
- The primary feasibility outcome was the proportion of eligible patients who provided informed consent, with a target threshold of 40%.
Main Results:
- The study is a pre-results trial, and main results are pending.
- Feasibility will be determined by achieving the target consent rate of 40% among eligible patients approached.
- Data on analgesic efficacy, safety, and tolerability will be collected for future analysis.
Conclusions:
- This pilot trial is designed to inform the methodology and feasibility of a definitive RCT comparing ketorolac and morphine for acute abdominal pain in children.
- Successful completion of this pilot study will support the initiation of a larger, multicenter trial to establish optimal pain management strategies.
- Findings will contribute to evidence-based guidelines for pediatric acute pain management, potentially shifting practice away from routine opioid use.
Objectives:
Despite a lack of evidence demonstrating superiority to non-steroidal anti-inflammatory drugs, like ketorolac, that are associated with lower risk of harms, opioids remain the most prescribed analgesic for acute abdominal pain. In this pilot trial, we will assess the feasibility of a definitive trial comparing ketorolac with morphine in children with suspected appendicitis. We hypothesise that our study will be feasible based on a 40% consent rate.
Methods And Analysis:
A single-centre, non-inferiority, blinded (participant, clinician, investigators and outcome assessors), double-dummy randomised controlled trial of children aged 6-17 years presenting to a paediatric emergency department with ≤5 days of moderate to severe abdominal pain (≥5 on a Verbal Numerical Rating Scale) and are investigated for appendicitis. We will use variable randomised blocks of 4-6 and allocate participants in 1:1 ratio to receive either intravenous (IV) ketorolac 0.5 mg/kg+IV morphine placebo or IV morphine 0.1 mg/kg+IV ketorolac placebo. Analgesic co-intervention will be limited to acetaminophen (commonly used as first-line therapy). Participants in both groups will be allowed rescue therapy (morphine 0.5 mg/kg) within 60 min of our intervention. Our primary feasibility outcome is the proportion of eligible patients approached who provide informed consent and are enrolled in our trial. Our threshold for feasibility will be to achieve a ≥40% consent rate, and we will enrol 100 participants into our pilot trial.
Ethics And Dissemination:
Our study has received full approval by the Hamilton integrated Research Ethics Board. We will disseminate our study findings at national and international paediatric research conferences to garner interest and engage sites for a future multicentre definitive trial.
Trial Registration:
NCT04528563, Pre-results.
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