Patient controlled analgesia (PCA) versus continuous infusion (CI) of morphine during vaso-occlusive crisis in sickle cell disease (SCD): a randomised controlled trial
| ISRCTN | ISRCTN74336585 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74336585 |
| Secondary identifying numbers | NTR647 |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 08/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr B.J. Biemond
Scientific
Scientific
Academic Medical Center (AMC)
Department of Clinical Chemistry
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5667391 |
|---|---|
| b.j.biemond@amc.uva.nl |
Study information
| Study design | Non-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The aim of our study is to determine the efficacy of PCA in vaso-occlusive crisis in patients with SCD. We will compare the effect of PCA versus standard CI morphine on cumulative morphine dose, mean daily dose and cumulative side-effects of morphine in a prospective randomised trial. In addition, quality of life and the effect on the duration of treatment and hospitalisation will be determined. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Sickle cell disease |
| Intervention | Patient controlled analgesia versus continuous infusion of morphine. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Morphine |
| Primary outcome measure | 1. Pain intensity 2. Side-effects 3. Morphine dosage |
| Secondary outcome measures | 1. Length of treatment 2. Hospital stay 3. Quality of life |
| Overall study start date | 04/10/2004 |
| Completion date | 14/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25 |
| Key inclusion criteria | 1. Sickle cell disease defined as HbSS, HbSC or HbSA (by electrophoresis) 2. Age greater than 17 years 3. The presence of typical pain recognised by patients as originating from vaso-occlusive crisis and which cannot be explained by other causes 4. Severe pain necessitating treatment with intravenous morphine 5. Written informed consent |
| Key exclusion criteria | 1. Patients already receiving opioids for more than 24 hours at time of randomisation 2. Allergy or intolerance for morphine 3. Pregnancy 4. Chronic use of opioids |
| Date of first enrolment | 04/10/2004 |
| Date of final enrolment | 14/04/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Heamatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (The Netherlands)
No information available
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 |
