Back to results

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

Primary Purpose

Sickle Cell Disease

Status

Terminated

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Ibuprofen

Placebo

Diamorphine or Morphine

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle Cell Disease, Pain, Ibuprofen, Morphine, Diamorphine, Patient Controlled Analgesia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

North West London Hospitals NHS Trust
Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Diamorphine or Morphine by PCA and oral ibuprofen

Diamorphine or Morphine by PCA and oral placebo

Outcomes

Primary Outcome Measures

Patient controlled analgesia (PCA)diamorphine or morphine consumption

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00880373

First Posted

April 9, 2009

Last Updated

December 3, 2012

Sponsor

London North West Healthcare NHS Trust

Collaborators

Medical Research Council CTU

1. Study Identification

Unique Protocol Identification Number

NCT00880373

Brief Title

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

Acronym

SWIM

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 Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Terminated

Why Stopped

The funding withdrawal and early termination of the trial is based upon lack of suitable recruitment figures in order to reach the required trial endpoints.

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

London North West Healthcare NHS Trust

Collaborators

Medical Research Council CTU

4. Oversight

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Disease

Keywords

Sickle Cell Disease, Pain, Ibuprofen, Morphine, Diamorphine, Patient Controlled Analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Diamorphine or Morphine by PCA and oral ibuprofen

Arm Title

Arm Type

Placebo Comparator

Arm Description

Diamorphine or Morphine by PCA and oral placebo

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo three times daily for 4 days

Intervention Type

Drug

Intervention Name(s)

Diamorphine or Morphine

Intervention Description

Diamorphine or Morphine by PCA

Primary Outcome Measure Information:

Title

Patient controlled analgesia (PCA)diamorphine or morphine consumption

Time Frame

4 days

Secondary Outcome Measure Information:

Title

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

Time Frame

4 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: