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New treatment option for Acute Pain
Official title Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain
ClinicalTrials.gov ID: NCT06160778
What this study is testing
What is Ketorolac Tromethamine?
Ketorolac Tromethamine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- Age 6 to 17 years
- Abdominal pain ≤5 days duration
- Acute abdominal pain that is being investigated (suspected) by the clinical team for appendicitis
- Patient with IV cannula in situ or ordered
- Currently experiencing moderate to severe abdominal pain at rest or with movement: self-reported pain score ≥5 using the verbal Numerical Rating Scale
You likely can't join if
- Previous enrollment in the trial
- 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).
- Children who need immediate resuscitation, are hemodynamically unstable as deemed by the clinical team or have a Canadian Triage Assessment Score of 1
- Significant caregiver and/or child cognitive impairment precluding the ability to complete study questions.
- Chronic pain requiring daily analgesic use: confounding as response to analgesics maybe altered.
- History of severe undiagnosed gastrointestinal bleeding requiring medical intervention, peptic or duodenal ulcer disease or inflammatory bowel...
See the full eligibility criteria
- Age 6 to 17 years
- Abdominal pain ≤5 days duration
- Acute abdominal pain that is being investigated (suspected) by the clinical team for appendicitis
- Patient with IV cannula in situ or ordered
- Currently experiencing moderate to severe abdominal pain at rest or with movement: self-reported pain score ≥5 using the verbal Numerical Rating Scale
- Previous enrollment in the trial
- 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).
- Children who need immediate resuscitation, are hemodynamically unstable as deemed by the clinical team or have a Canadian Triage Assessment Score of 1
- Significant caregiver and/or child cognitive impairment precluding the ability to complete study questions.
- Chronic pain requiring daily analgesic use: confounding as response to analgesics maybe altered.
- History of severe undiagnosed gastrointestinal bleeding requiring medical intervention, peptic or duodenal ulcer disease or inflammatory bowel disease, coagulation disorders, prior cerebrovascular bleeding, known...
- History of chronic and active interstitial kidney disease
- History of chronic and active hepatocellular disease: ketorolac is metabolized by the liver.
- Known or suspected pregnancy at the time of enrollment or breastfeeding females
- Known hypersensitivity to NSAIDs or opioids.
- Absence of a parent/guardian for children who are \<16 years of age if they are not a mature minor.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.