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Nonsteroidal Anti-Inflammatory Drug

Ketorolac vs. Morphine for Acute Abdominal Pain in Children (KETOAPP Trial)

Phase 3
Recruiting
Led By Mohamed Eltorki, MBChB
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute abdominal pain being investigated for appendicitis by the clinical team
Patient with IV cannula in situ or ordered
Must not have
Significant caregiver and/or child cognitive impairment precluding the ability to complete study questions
Inability to obtain consent due to a language barrier and the absence of a language translator in person or by a phone translation service available in the ED
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes post drug administration
Awards & highlights

Summary

This trial aims to determine if children with belly pain can be treated effectively with the non-opioid medication ketorolac instead of morphine. The study will involve a large number of school-aged

Who is the study for?
This trial is for children aged 6-17 with severe belly pain, suspected of appendicitis, and who have or will get an IV. They must be in moderate to severe pain at rest or when moving, scoring ≥5 on a pain scale.
What is being tested?
The study compares the effectiveness of Ketorolac (a non-opioid) versus Morphine (an opioid) for treating acute abdominal pain in children. Participants are randomly given one dose of either drug without knowing which one they received.
What are the potential side effects?
Ketorolac may cause less side effects than morphine and is generally safer for short-term use. Morphine can lead to risks like addiction, drowsiness, nausea, constipation, and breathing problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am being checked for appendicitis due to acute abdominal pain.
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I have an IV line in place or one has been ordered for me.
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I am between 6 and 17 years old.
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I am experiencing significant abdominal pain, rating it 5 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I or my caregiver/child cannot complete study questions due to cognitive issues.
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I cannot give consent because there's no translator for my language.
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My child is in critical condition and needs immediate help.
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I need painkillers every day for chronic pain.
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I have a long-term kidney condition that affects the tissue between my kidney tubules.
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I have a long-term liver disease.
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I have a history of serious bleeding or blood clotting disorders.
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I am under 16 and do not have a parent or guardian available, but I am considered a mature minor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes post drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes post drug administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Additional analgesia requirment
Adverse events per participant
Change in baseline pain category
+7 more
Other study objectives
Appendix visualization on ultrasound

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ketorolac TromethamineExperimental Treatment2 Interventions
Ketorolac tromethamine, an NSAID belonging to a group of non-opioid analgesics that inhibit the synthesis of prostaglandins and thromboxanes with strong analgesic and anti-inflammatory properties. It is the only non-opioid parenteral non-sedating analgesic available in Canada for use to treat acute pain in the emergency department.
Group II: Morphine SulfateActive Control2 Interventions
An intravenous opioid that is commonly used as part of usual care for treament of pain in patients with acute abdominal pain and suspected appendicitis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
normal saline
2010
Completed Phase 4
~2680
Ketorolac Tromethamine
2007
Completed Phase 4
~1450

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,373 Previous Clinical Trials
26,518,747 Total Patients Enrolled
University of CalgaryLead Sponsor
805 Previous Clinical Trials
883,537 Total Patients Enrolled
Mohamed Eltorki, MBChBPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
105 Total Patients Enrolled
~330 spots leftby Jan 2029
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