Recruiting
Phase 3

Ketorolac vs. Morphine

Sponsor:

University of Calgary

Code:

NCT06160778

Conditions

Acute Pain

Abdomen, Acute

Abdominal Pain

Appendicitis

Emergencies

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Ketorolac Tromethamine

Morphine Sulfate

normal saline

Normal saline

Study Details

Brief 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.

Conditions

Acute Pain

Abdomen, Acute

Abdominal Pain

Appendicitis

Emergencies

Study ID

NCT06160778

Start date

May 27, 2024

Status verified date

Nov, 2023

Completion date

Dec, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

495 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketorolac Tromethamine

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.

active comparator: Morphine Sulfate

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.

Interventions

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.

Primary outcome measure

  • Pain relief as measured on the verbal numerical rating scale [ Time Frame: 60 minutes post drug administration ]

Central Contacts and Locations

Central contacts

Locations

Alberta Children's Hospital Emergency Department

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

More Information

Sponsor

University of Calgary

Last update posted

Jun 24, 2024

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2024-06-24.