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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes post drug administration

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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