Clinical trial to assess efficacy and safety of a new formulation of ibuprofen 800 mg in the treatment of postoperative pain.
- Conditions
- Moderate to severe postoperative pain.MedDRA version: 14.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2011-005007-33-ES
- Lead Sponsor
- aboratorios Biomendi S.A.U.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Men or women between 18 and 80 years old.
2. Being scheduled for elective single surgical site orthopaedic surgery (hip or knee joint replacement), or abdominal surgery (inguinal hernia, cholecystectomy).
3. Being scheduled for general anaesthesia.
4. Having anticipated need for postoperative narcotic analgesia administered by patient controlled analgesia (PCA).
5. Expected to stay at the hospital for at least 24 h.
6. Providing written informed consent for participating in this study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160
1. Use of NSAID within 12 hours prior to the first planned dose.
2. Taking oral anticoagulants, lithium, combination of ACE inhibitors, furosemide or aspirin.
3. Anaemia and/or history or evidence of asthma or heart failure.
4. History of allergy or hypersensitivity to any component of IV ibuprofen, aspirin or aspirin related products, NSAID or COX-2 inhibitors.
5. Pregnant or nursing.
6. Weight less than 40 kg.
7. 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.
8. History of congenital bleeding diathesis or any active clinically significant bleeding or underlying platelet dysfunction.
9. Gastrointestinal bleeding that required medical intervention.
10. Peptip ulcer antecedents or inflammatory bowel disease.
11. Patients with severe cardiac insufficiency and/or ischemic cardiomyopathy.
12. Platelet count less than 80.000 determined within the 28 days prior to surgery.
13. Pre-existing dependence on narcotics or receiving chronic treatment with opioids.
14. Severe renal failure.
15. Liver failure, ALAT or ASAT > 3 times upper limit of normality, or bilirrubin > 2 g/dl.
16. Diagnosed of Bowel Inflammatory Disease.
17. Not able to understand the requirements of the study, or to abide by the study restrictions or to return for the required assessments.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain.;Secondary Objective: To evaluate the tolerability and safety profile.;Primary end point(s): Reduction in total morphine use in the first 24 hours post-surgery as compared to placebo.;Timepoint(s) of evaluation of this end point: 24 hours after surgery
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Consumption of morphine in the first 48 h (and 72 h) post-surgery.<br>- Pain intensity at rest and with movement measured with the eleven points visual analogue scale (VAS).<br>- Ramsay-Hunt sedation scale.<br>- Time to first subsequent narcotic analgesia (or time to treatment failure).<br>- Number of doses of morphine and number of attempts of dosing at PCA.<br>- Nocturnal awakenings due to pain.<br>- Adverse events during the study.<br>- Local reactions due to IV infusion.<br>- Vital signs.<br>- Routine laboratory tests.;Timepoint(s) of evaluation of this end point: Between 2-4 days after last ibuprofen dose.