Ibuprofen and morphine for acute pain in sickle cell disease
| ISRCTN | ISRCTN97241637 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97241637 |
| ClinicalTrials.gov number | NCT00880373 |
| Secondary identifying numbers | HTA 07/48/01 |
- 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
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=92
Contact information
Dr Kofi Anie
Scientific
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 |
|---|---|
| Kofi.Anie@nwlh.nhs.uk |
Study information
| Study design | Double-blind placebo-controlled randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(s) | London Research Ethics Committee, 27/02/2009, ref: 08/H0718/79 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ibuprofen, morphine |
| Primary outcome measure | 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 study start date | 01/09/2009 |
| Overall study end 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 | Both |
| Target number of participants | 320 |
| Participant inclusion criteria | Adult patients with SCD of any phenotype and gender aged 16 years and over. |
| 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
- England
- United Kingdom
Study participating centre
North West London Hospitals NHS Trust
London
NW10 7NS
United Kingdom
NW10 7NS
United Kingdom
Sponsor information
North West London Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development
Northwick Park Hospital
Watford Road
Harrow
Middlesex
HA1 3UJ
England
United Kingdom
| Phone | +44 (0)20 8869 2011 |
|---|---|
| Research@nwlh.nhs.uk | |
| Website | http://www.nwlh.nhs.uk |
"ROR" |
https://ror.org/04cntmc13 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | why trial was stopped: | 09/06/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/06/2016: Publication reference added.
07/01/2013: Please note that this trial was stopped due to a slow recruitment rate.
