A Multicenter, Randomized, Double-blind, and Parallel Groups, Placebo-controlled Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative Pain.
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 231
- Locations
- 13
- Primary Endpoint
- Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo
Study Overview
Brief Summary
The purpose of this study is to study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain and evaluate its tolerability and safety profile.
Detailed Description
This is a phase III, national, multicenter, randomized, double-blind, parallel groups, and placebo-controlled.
Patients will be randomized to receive either ibuprofen or placebo. Stratified randomization will be used to assign eligible patients to a stratum according to type of surgery and centre. Randomization sequence will be generated in the coordinating centre.
Blinding of the patient and study personnel evaluating response will be warranted by adequate drug labelling.
All patients will receive morphine administered by patient controlled analgesia (PCA) following a similar schedule in all centres: 1 mg bolus dose with a close time of 5 min and a maximum of 10 mg in an hour and a maximum of 30 mg in 4 hours.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men or women between 18 and 80 years old.
- •Being scheduled for elective single surgical site orthopaedic surgery (hip or knee joint replacement, corsed ligaments, column or shoulder surgery), or abdominal surgery (inguinal hernia, cholecystectomy, eventration or hiatus hernia)
- •Being scheduled for general anaesthesia or regional anesthesia without regional analgesia after surgery.
- •Having anticipated need for postoperative narcotic analgesia administered by patient controlled analgesia (PCA).
- •Expected to stay at the hospital for at least 24 h.
- •Providing written informed consent for participating in this study.
Exclusion Criteria
- •Use of NSAID within 12 hours prior to the first planned dose.
- •Taking oral anticoagulants, lithium, combination of ACE inhibitors, furosemide or aspirin.
- •Anaemia (haemoglobin <10 g/dl) and/or history or evidence of asthma or heart failure.
- •History of allergy or hypersensitivity to any component of IV ibuprofen, aspirin or aspirin related products, NSAID or COX-2 inhibitors.
- •Pregnant or nursing.
- •Weight less than 40 kg.
- •History of severe head trauma that required hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or CNS mass lesion.
- •History of congenital bleeding diathesis or any active clinically significant bleeding or underlying platelet dysfunction.
- •Gastrointestinal bleeding that required medical intervention.
- •Platelet count less than 80.000 determined within the 28 days prior to surgery.
- •Pre-existing dependence on narcotics or receiving chronic treatment with opioids.
- •Severe renal failure (calculated creatinine clearance < 60 ml/min).
- •Liver failure, ALAT or ASAT >3 times upper limit of normality, or bilirubin >2 g/dl.
- •Diagnosed of Bowel Inflammatory Disease.
- •Not able to understand the requirements of the study, or to abide by the study restrictions or to return for the required assessments.
Arms & Interventions
800 mg intravenous ibuprofen
Treatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours, infused over 15 minutes.
Intervention: Intravenous ibuprofen (Drug)
200 ml of saline solution
Placebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours, infused over 15 min.
Intervention: Saline solution (Drug)
Outcomes
Primary Outcomes
Evaluate the efficacy of intravenous ibuprofen for the management of postoperative pain in comparison to placebo
Time Frame: First 24 hours post- surgery
The primary efficacy endpoint will be the reduction in total morphine use in the first 24 hours post- surgery as compared to placebo.
Secondary Outcomes
- Secondary tolerability and safety endpoints(From 0 hours to 72 hours post- surgery)
- Secondary efficacy endpoints(From 0 hours to 72 hours post- surgery)