SWIM: Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease - Sickle With Ibuprofen & Morphine

Sponsor

London North West Healthcare NHS Trust (Other)

Overall Status

Terminated

CT.gov ID

NCT00880373

Collaborator

Medical Research Council CTU (Other)

320

Enrollment

Locations

Arms

Duration (Months)

160

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The use of oral ibuprofen combined with Opioid (Morphine or Diamorphine) administered through patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in adults with sickle cell disease (SCD).

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease	Drug: Ibuprofen Drug: Placebo Drug: Diamorphine or Morphine	Phase 4

Detailed Description

Pain from vaso-occlusion in sickle cell disease (SCD) is persistent, and its management continues to pose a challenge to practitioners. Opioids are recommended for the treatment of severe acute SCD pain, and have been used successfully within the hospital setting. Non-steroidal Anti-Inflammatory Drugs (NSAIDs) are recommended for acute SCD pain, however there is no clear evidence for the effectiveness of oral NSAIDs in combination with parenteral opioids in adults with SCD.Data from acute pain research suggests that oral ibuprofen is one of the best NSAIDs for combination treatment with morphine via PCA.

This is a randomised controlled trail to evaluate the effectiveness of oral ibuprofen plus intravenous Diamorphine or morphine via PCA. The results will provide the evidence needed to recommend whether or not ibuprofen should be used in acute SCD pain.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

An Evaluation of the Effectiveness of Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease: a Double-blind, Placebo-controlled Randomised Trial

Study Start Date :

Mar 1, 2011

Anticipated Primary Completion Date :

Mar 1, 2014

Anticipated Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Diamorphine or Morphine by PCA and oral ibuprofen	Drug: Ibuprofen Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days Drug: Diamorphine or Morphine Diamorphine or Morphine by PCA
Placebo Comparator: 2 Diamorphine or Morphine by PCA and oral placebo	Drug: Placebo Matching placebo three times daily for 4 days Drug: Diamorphine or Morphine Diamorphine or Morphine by PCA

Arm

Intervention/Treatment

Active Comparator: 1

Diamorphine or Morphine by PCA and oral ibuprofen

Drug: Ibuprofen

Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days

Drug: Diamorphine or Morphine

Diamorphine or Morphine by PCA

Placebo Comparator: 2

Diamorphine or Morphine by PCA and oral placebo

Drug: Placebo

Matching placebo three times daily for 4 days

Drug: Diamorphine or Morphine

Diamorphine or Morphine by PCA

Outcome Measures

Primary Outcome Measures

Patient controlled analgesia (PCA)diamorphine or morphine consumption [4 days]

Secondary Outcome Measures

Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale [4 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients with SCD of any phenotype

Exclusion Criteria:

Patient has a history of allergic reaction to either diamorphine/morphine or ibuprofen
Patient has contraindications to diamorphine/morphine or ibuprofen, e.g. peptic ulcer disease, non-steroidal anti-inflammatory drug (NSAID)-induced asthma
Patient in a drug dependency programme
Patient is on renal dialysis
Stroke within the last 6 weeks
Platelet count less than 50 x 10^9/l
Patient is pregnant or breastfeeding
Doctor unwilling to randomise the patient for other reasons
Previous participation in the trial
Patient receiving drug treatment with which opioids or NSAIDs are likely to interact significantly
Stage 1 - 5 chronic kidney disease (ref Appendix 2), including urine protein: creatinine ratio of >50 (Because the ibuprofen dose is substantial it is felt that precautions should be taken to exclude those who have any signs of chronic kidney disease. One of the signs of kidney disease is "persistent proteinuria". Therefore, the patient who intermittently has proteinuria(which could be due to other reasons) could still participate.)
Oxygen saturation by pulse oximetry <94%
Participation in another clinical trial within the last month

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North West London Hospitals NHS Trust	London		United Kingdom	NW10 7NS
2	Imperial College Healthcare NHS Trust	London		United Kingdom	W12 0HS

Sponsors and Collaborators

London North West Healthcare NHS Trust
Medical Research Council CTU

Investigators

Principal Investigator: Kofi A Anie, PhD, London North West Healthcare NHS Trust
Study Chair: Gavin Cho, MD, London North West Healthcare NHS Trust
Principal Investigator: Mark Layton, MD, Imperial College London
Study Director: Sarah Meredith, MD, MRC Clinical Trials Unit
Study Director: Caroline Dore, BSc, MRC Clinical Trials Unit