Status:
COMPLETED
Ketorolac for Moderate to Severe Abdominal Pain in Children
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Abdominal Pain
Appendicitis
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
In children and adolescents (older than 6 years in age) who arrive in the pediatric emergency department because they have been having 5 days or less of abdominal pain (possible appendicitis), will pa...
Detailed Description
Background/Rationale: Appendicitis is the most common emergent surgical diagnosis among children between 5-17 years in age and accounts for 8000 admissions annually. Diagnosing appendicitis is time co...
Eligibility Criteria
Inclusion
- Age 6.0 years to \<18 years: Children aged \< 6 years of age at low risk for appendicitis and often present atypically.46,47
- Duration of abdominal pain ≤ 5 days: Children with longer durations of acute abdominal pain are less likely to have appendicitis.18,48
- A clinical decision to investigate for appendicitis as a possible etiology by the ED MD or RN. The physician or bedside nurse are suspicious of a diagnosis of appendicitis as a cause for the abdominal pain as reflected by the initiation of the appendicitis medical directive (an advanced nursing directive that allows nurses to order tests for patients with suspected appendicitis) and order laboratory tests and/or advanced imaging or directly consult pediatric surgery to rule out appendicitis.
- Patient has an IV cannula in situ or ordered to be placed: we will not include patients without an IV ordered or established in order to ensure the study intervention is limited to the study drugs and is not associated with the performance of any invasive procedures.
- Currently experiencing moderate to severe pain: self-reported pain score ≥5 using the VNRS at the time of enrollment.
Exclusion
- Previous enrollment in trial (to ensure all observations are independent and not paired)
- NSAID use within 3 hours and/or opioid use within 2 hours prior to recruitment to avoid over-dosing and confounding
- Caregiver and/or child cognitive impairment precluding the ability to self-report pain or respond to study questions
- Chronic pain requiring daily analgesic use for other indications (e.g. naproxen for juvenile idiopathic arthritis): confounding
- History of gastrointestinal bleeding, peptic or duodenal ulcer disease or inflammatory bowel disease, coagulation disorders, prior cerebrovascular bleeding, known arterio-vascular malformations: Bleeding risk
- History of chronic and active renal disease, excluding renal calculi and urinary tract infections
- History of chronic and active hepatocellular disease (excludes biliary stones, cholangitis or biliary duct pathology), as ketorolac is metabolized in the liver.
- Known pregnancy at the time of enrollment, a positive pregnancy test in females ≥ 12 years in age or breastfeeding females due to the risk of premature closure of patent ductus arteriosus
- Known hypersensitivity to NSAIDs or opioids (e.g. naproxen, ibuprofen, acetylsalicylic acid, ketoprofen or ketorolac, morphine, hydromorphone, fentanyl)
- Absence of a parent/guardian for children who are \< 16 years in age: youths who are ≥16 years can provide us with informed consent without the permission of a guardian
- Inability to obtain consent due to a significant language barrier, in the absence of a native language translator
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2023
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04528563
Start Date
May 5 2021
End Date
February 6 2023
Last Update
February 28 2023
Active Locations (1)
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1
McMaster Children's Hospital
Hamilton, Ontario, Canada, L9H6k6