Intravenous Ketorolac Vs. Morphine In Children Presenting With Suspected Appendicitis: A Pilot Single Center Non Inferiority Randomised Controlled Trial

582125

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 patients who are treated with ketorolac get just as much pain relief as those patients treated with morphine? To answer this research question, we will need a large number of patients in a study. To ensure we have enough patients, we must include many hospitals in different cities and provinces in the same study. Before doing this, though, we must first test a smaller version of the study in our center at McMaster Children's hosptial. The goal of doing this at McMaster first is to make sure or understand: 1. We can enroll enough people in our study over 1 year 2. We can make sure that all the information we collect from patients is complete and nothing is missing 3. Reasons behind why people don't want to participate in the study 4. How satisfied patients and their caregivers were with the study

2021-05-05

2023-02-05

2023-02-06

Completed

Early phase I

105

Inclusion Criteria: 1. Age 6.0 years to \<18 years: Children aged \< 6 years of age at low risk for appendicitis and often present atypically.46,47 2. Duration of abdominal pain ≤ 5 days: Children with longer durations of acute abdominal pain are less likely to have appendicitis.18,48 3. 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. 4. 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. 5. Currently experiencing moderate to severe pain: self-reported pain score ≥5 using the VNRS at the time of enrollment. Exclusion Criteria: 1. Previous enrollment in trial (to ensure all observations are independent and not paired) 2. NSAID use within 3 hours and/or opioid use within 2 hours prior to recruitment to avoid over-dosing and confounding 3. Caregiver and/or child cognitive impairment precluding the ability to self-report pain or respond to study questions 4. Chronic pain requiring daily analgesic use for other indications (e.g. naproxen for juvenile idiopathic arthritis): confounding 5. History of gastrointestinal bleeding, peptic or duodenal ulcer disease or inflammatory bowel disease, coagulation disorders, prior cerebrovascular bleeding, known arterio-vascular malformations: Bleeding risk 6. History of chronic and active renal disease, excluding renal calculi and urinary tract infections 7. History of chronic and active hepatocellular disease (excludes biliary stones, cholangitis or biliary duct pathology), as ketorolac is metabolized in the liver. 8. 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 9. Known hypersensitivity to NSAIDs or opioids (e.g. naproxen, ibuprofen, acetylsalicylic acid, ketoprofen or ketorolac, morphine, hydromorphone, fentanyl) 10. 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 11. Inability to obtain consent due to a significant language barrier, in the absence of a native language translator

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double dummy design', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 105, 'type': 'ACTUAL'}}

2023-02-28