An Evaluation of the Effectiveness of Ibuprofen and Morphine for Acute Pain in Sickle Cell Disease

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2008
INTERVENTION: Trade Name: Nurofen Caplets Product Name: Ibuprofen Pharmaceutical Form: Capsule* INN or Proposed INN: IBUPROFEN CAS Number: 15687271 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Placebo Product Code: n/a Pharmaceutical Form: Capsule* CONDITION: Sickle Cell Disease PRIMARY OUTCOME: Main Objective: To assess the clinical effectiveness of oral ibuprofen combined with morphine administered through patient controlled analgesia for acute pain crisis in adults with sickle cell disease. Primary end point(s): Morphine consumption through patient controlled analgesia (PCA) pump over 4 days Secondary Objective: To determine if oral ibuprofen combined with morphine administered through patient controlled analgesia for acute sickle cell pain leads to an improvement in the overall experience of hospital admissions in patients with sickle cell disease.; ; To assess the cost effectiveness of oral ibuprofen combined with morphine administered through patient controlled analgesia for acute pain crisis in adults with sickle cell disease.; INCLUSION CRITERIA: Adult patients with SCD of any phenotype and gender aged 16 years and over Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 929d5cce83aa436af086de364447a0d7947ecd29
First added on: Aug 21, 2024