Ibuprofen and morphine for acute pain in sickle cell disease

Not Applicable

Completed

• Conditions: Sickle cell disease; Haematological Disorders; Sickle-cell disorders

• Registration Number: ISRCTN97241637
• Lead Sponsor: orth West London Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-08
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Adult patients with SCD of any phenotype and gender aged 16 years and over.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PCA morphine consumption over 4 days

Secondary Outcome Measures

Name	Time	Method
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)<br>2. Mood - measured on the Hospital Anxiety and Depression Scale (HADS)<br>3. Adverse opioid effects - including nausea, constipation, itching, and central nervous system effects<br>4. Other sickle cell complications - including neurological events, and acute chest syndrome<br>5. Use of blood transfusions - treatment for complications during or post-discharge study period of 4 weeks<br>6. Health service utilisation cost - length of hospital admission, and re-admission in 7 - 14 days<br>7. Quality of life and utility - measured on the EuroQol (EQ-5D)<br>8. Patient satisfaction - patient experience at discharge