Condition category
Haematological Disorders
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
08/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr B.J. Biemond

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Clinical Chemistry
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5667391
b.j.biemond@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR647

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Non-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Sickle cell disease

Intervention

Patient controlled analgesia versus continuous infusion of morphine.

Intervention type

Drug

Phase

Not Specified

Drug names

Morphine

Primary outcome measures

1. Pain intensity
2. Side-effects
3. Morphine dosage

Secondary outcome measures

1. Length of treatment
2. Hospital stay
3. Quality of life

Overall trial start date

04/10/2004

Overall trial end date

14/04/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

Participant 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

Recruitment start date

04/10/2004

Recruitment end date

14/04/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Heamatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes