Ibuprofen and morphine for acute pain in sickle cell disease

ISRCTN	ISRCTN97241637
DOI	https://doi.org/10.1186/ISRCTN97241637
ClinicalTrials.gov (NCT)	NCT00880373
Protocol serial number	HTA 07/48/01
Sponsor	North West London Hospitals NHS Trust (UK)
Funder	Health Technology Assessment Programme

Submission date: 03/04/2009
Registration date: 08/04/2009
Last edited: 13/06/2016

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=92

Contact information

Dr Kofi Anie
Scientific

Haematology and Sickle Cell Centre
North West London Hospitals NHS Trust
Central Middlesex Hospital
Acton Lane
London
NW10 7NS
United Kingdom

Phone	+44 (0)20 8453 2050
Email	Kofi.Anie@nwlh.nhs.uk

Study information

Primary study design	Interventional
Study design	Double-blind placebo-controlled randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	An evaluation of the effectiveness of ibuprofen and morphine for acute pain in sickle cell disease: a double-blind, placebo-controlled randomised trial
Study acronym	SWIM (Sickle With Ibuprofen and Morphine)
Study objectives	The use of oral ibuprofen combined with morphine administered through patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in adults with sickle cell disease (SCD). More details can be found at: http://www.hta.ac.uk/1782 Protocol can be found at: http://www.hta.ac.uk/protocols/200700480001.pdf
Ethics approval(s)	London Research Ethics Committee, 27/02/2009, ref: 08/H0718/79
Health condition(s) or problem(s) studied	Sickle cell disease
Intervention	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 treatment groups: 1. Morphine by PCA and oral ibuprofen 2. Morphine by PCA and oral placebo Follow-up is at 1 week and 4 weeks post-discharge for both treatment groups.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ibuprofen, morphine
Primary outcome measure(s)	PCA morphine consumption over 4 days
Key secondary outcome measure(s)	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
Completion date	31/08/2013
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	All
Target sample size at registration	320
Key inclusion criteria	Adult patients with SCD of any phenotype and gender aged 16 years and over.
Key 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
Date of first enrolment	01/09/2009
Date of final enrolment	31/08/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

North West London Hospitals NHS Trust

London
NW10 7NS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Other publications	why trial was stopped:	09/06/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/06/2016: Publication reference added.

07/01/2013: Please note that this trial was stopped due to a slow recruitment rate.