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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006846-24-GB

Enrollment

320

Registered

2008-12-12

Start date

2009-02-27

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Interventions

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 Conc

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Patient has a history of allergic reaction to either morphine or ibuprofen 2. Patient has contraindications to morphine or ibuprofen, e.g. peptic ulcer disease, NSAID-induced asthma 3. Patient in a drug dependency programme 4. Patient is on renal dialysis 5. Stroke within the last 6 weeks 6. Platelet count < 50 X 10E9/l 7. Patient is pregnant or breastfeeding 8. Doctor unwilling to randomise the patient for other reasons 9. Previous participation in the trial

Design outcomes

Primary

Measure	Time frame
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.;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. ;Primary end point(s): Morphine consumption through patient controlled analgesia (PCA) pump over 4 days	—

Measure

Time frame

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.;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. ;Primary end point(s): Morphine consumption through patient controlled analgesia (PCA) pump over 4 days

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026