Condition category
Haematological Disorders
Date applied
03/04/2009
Date assigned
08/04/2009
Last edited
13/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Contact information

Type

Scientific

Primary contact

Dr Kofi Anie

ORCID ID

Contact details

Haematology and Sickle Cell Centre
North West London Hospitals NHS Trust
Central Middlesex Hospital
Acton Lane
London
NW10 7NS
United Kingdom
+44 (0)20 8453 2050
Kofi.Anie@nwlh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00880373

Protocol/serial number

HTA 07/48/01

Study information

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

Acronym

SWIM (Sickle With Ibuprofen and Morphine)

Study hypothesis

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

London Research Ethics Committee, 27/02/2009, ref: 08/H0718/79

Study design

Double-blind placebo-controlled randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Ibuprofen, morphine

Primary outcome measures

PCA morphine consumption over 4 days

Secondary outcome measures

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

Overall trial start date

01/09/2009

Overall trial end date

31/08/2013

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

320

Participant 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

Recruitment start date

01/09/2009

Recruitment end date

31/08/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North West London Hospitals NHS Trust
London
NW10 7NS
United Kingdom

Sponsor information

Organisation

North West London Hospitals NHS Trust (UK)

Sponsor details

Research and Development
Northwick Park Hospital
Watford Road
Harrow
Middlesex
HA1 3UJ
United Kingdom
+44 (0)20 8869 2011
Research@nwlh.nhs.uk

Sponsor type

Government

Website

http://www.nwlh.nhs.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 why trial was stopped: http://www.ncbi.nlm.nih.gov/pubmed/27288381

Publication citations

Additional files

Editorial Notes

13/06/2016: Publication reference added. 07/01/2013: Please note that this trial was stopped due to a slow recruitment rate.