Sickle cell disease Haematological Disorders Sickle-cell disorders
Conditions
Interventions
Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days. There will be a matching placebo for each active drug. Participants will be randomly allocated to one of two treatmen
Sponsors
North West London Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients with SCD of any phenotype and gender aged 16 years and over.
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, non-steroidal anti-inflammatory drug (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 less than 50 x 10^9/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 |
|---|---|
| PCA morphine consumption over 4 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale within 4 days (based on assessments of patients attending Central Middlesex Hospital) 2. Mood - measured on the Hospital Anxiety and Depression Scale (HADS) 3. Adverse opioid effects - including nausea, constipation, itching, and central nervous system effects 4. Other sickle cell complications - including neurological events, and acute chest syndrome 5. Use of blood transfusions - treatment for complications during or post-discharge study period of 4 weeks 6. Health service utilisation cost - length of hospital admission, and re-admission in 7 - 14 days 7. Quality of life and utility - measured on the EuroQol (EQ-5D) 8. Patient satisfaction - patient experience at discharge | — |
Countries
United Kingdom
Outcome results
None listed