Comparison of Ketorolac at Three Doses in Children With Acute Pain (KETODOSE)
Acute Pain, Abdominal Pain, Migraine
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
Inclusion Criteria: Age 6.0 years to <18 years: primary outcome measure, 11-point vNRS is validated for use in children ≥6 years, and no other evidence-based acute pain measure is recommended for use in younger children Currently experiencing moderate to severe pain (self-reported pain score >4 using the vNRS at the time of enrollment; ketorolac is used to treat moderate to severe pain) Patients seen in the ED or inpatient setting with acute pain ≤30 days in duration Patient with IV cannula in situ or ordered (to minimize any additional pain or distress) Exclusion Criteria: Previous enrollment in trial (to ensure all observations are independent and not paired) Post-operative patient (as this included medically induced pain, versus pathology-only) Ketorolac 6 hours and/or opioids 4 hours prior to recruitment (avoid over-dosing and confounding) Use of daily analgesic for any indications (confounding as response to analgesics maybe altered) Caregiver and/or child cognitive impairment (precludes the ability to respond to study questions) History of gastrointestinal bleed or ulcers, inflammatory bowel disease, coagulation disorders, cerebrovascular bleeding, known arterio-vascular malformations (increased bleeding risk) History of chronic and active renal disease, excluding renal calculi and urinary tract infections History of chronic and active hepatocellular disease (ketorolac is metabolized in the liver) Known pregnancy at the time of enrollment (risk of closure of patent ductus arteriosus in fetus) Known hypersensitivity to NSAIDs or opioids Inability to obtain consent (language barrier and the absence of language translator)
Sites / Locations
- McMaster University Medical CentreRecruiting
- McMaster Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Standard dose group A
Low dose group B1
Low dose group B2
IV ketorolac 0.5 mg/kg/dose up to a maximum dose of 30 mg plus IV normal saline placebo given at 0.25 mg/kg to a maximum of 30 mg plus IV normal saline placebo given at 0.5 mg/kg to a maximum of 10 mg
IV ketorolac 0.5 mg/kg to a maximum of 10 mg plus IV normal saline placebo given at 0.25 mg/kg to a maximum of 30 mg plus IV normal saline placebo given at 0.5 mg/kg to a maximum of 30 mg
IV ketorolac 0.25 mg/kg to a maximum of 30 mg plus IV normal saline placebo given at 0.5 mg/kg to a maximum of 30 mg plus IV normal saline placebo 0.5 mg/kg to a maximum of 10 mg