Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain

NCT06160778 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Calgary

Phase

Phase 3

Started

2024-05-27

Last updated

2024-06-24

Condition(s) studied

Acute PainAbdomen, AcuteAbdominal PainAppendicitisEmergenciesChild, Only

Investigational drug(s) / intervention(s)

Ketorolac Tromethamine →Morphine Sulfate →normal salineNormal saline

Ketorolac Tromethamine: Intravenous ketorolac given at 0.5 mg/kg of body weight up to a maximum of 30 mg in a single dose.

Morphine Sulfate: Intravenous morphine given at 0.1 mg/kg of body weight up to a maximum of 5 mg in a single dose.

normal saline: Intravenous normal saline placebo (labelled as morphine) given at 0.1 mg/kg of body weight up to a maximum of 5 mg in a single dose.

Normal saline: Intravenous normal saline placebo (labelled as ketorolac) given at 0.5 mg/kg of body weight up to a maximum of 30 mg in a single dose.

Study summary

Appendicitis is a common condition in children 6-17 years of age, and the top reason for emergency surgery in Canada. Children with appendicitis can have very bad pain in their belly. Children often need pain medications given to them through a needle in their arm called an intravenous (IV). The most common IV pain medication is a type of opioid called morphine. We know that opioids work well to improve pain, but there are risks and side effects when taking them. There are non-opioid medications that doctors can give to patients, like ketorolac. Ketorolac helps decrease inflammation and pain and has fewer side effects when a patient takes it for a short period of time. Our past and present overuse of opioids, driven by an unproven assumption that opioids work best for pain, resulted in an Opioid Crisis and doctors are now looking for alternatives. To do this, we need to prove that there are other options to treat children's pain that are just as good as opioids, with less side effects.

The goal of our study is to discover if school aged children who arrive at the emergency department with belly pain, improve just as much with ketorolac as they do with morphine. To answer this question, we will need a very large number of patients in a study that includes several hospitals across Canada. With a flip of a coin, each participant will either get a single dose of morphine or a single dose of ketorolac. To make sure that our pain assessment is impartial, no one will know which medicine the child received except the pharmacist who prepared the medicine.

Eligibility

Sex

ALL

Min age

6 Years

Max age

17 Years

Healthy volunteers

Inclusion Criteria: 1. Age 6 to 17 years 2. Abdominal pain ≤5 days duration 3. Acute abdominal pain that is being investigated (suspected) by the clinical team for appendicitis 4. Patient with IV cannula in situ or ordered 5. Currently experiencing moderate to severe abdominal pain at rest or with movement: self-reported pain score ≥5 using the verbal Numerical Rating Scale Exclusion Criteria: 1. Previous enrollment in the trial 2. NSAID use within 3 hours and/or opioid use within 1 to 2 hours (1 hour post-IV or intra-nasal fentanyl and 2 hours post IV morphine). 3. Children who need immediate resuscitation, are hemodynamically unstable as deemed by the clinical team or have a Canadian Triage Assessment Score of 1 4. Significant caregiver and/or child cognitive impairment precluding the ability to complete study questions. 5. Chronic pain requiring daily analgesic use: confounding as response to analgesics maybe altered. 6. History of severe undiagnosed gastrointestinal bleeding requiring medical intervention, peptic or duodenal ulcer disease or inflammatory bowel disease, coagulation disorders, prior cerebrovascular bleeding, known arterio-vascular malformations. History of minor gastrointestinal bleeding from conditions such as resolved fissures, polyps or allergic colitis will not exclude patients from participating. 7. History of chronic and active interstitial kidney disease 8. History of chronic and active hepatocellular disease: ketorolac is metabolized by the liver. 9. Known or suspected pregnancy at the time of enrollment or breastfeeding females 10. Known hypersensitivity to NSAIDs or opioids. 11. Absence of a parent/guardian for children who are \<16 years of age if they are not a mature minor. 12. Inability to obtain consent due to a language barrier and the absence of language translator in person or by a phone translation service available in the ED.

Primary outcome measure(s)

Pain relief as measured on the verbal numerical rating scale — 60 minutes post drug administration
Between group mean differences in pain as measured on an 11-point verbal Numerical Rating Scale (0 is no pain and 10 is worst pain ever)

Trial sites (1)

Facility	City	Region	Status
Alberta Children's Hospital Emergency Department	Calgary	Alberta	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06160778 on ClinicalTrials.gov ↗ ← All trials in Canada