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
Protocol serial number	NTR647
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Academic Medical Centre (AMC) (The Netherlands)

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

Dr B.J. Biemond
Scientific

Academic Medical Center (AMC)
Department of Clinical Chemistry
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5667391
Email	b.j.biemond@amc.uva.nl

Primary study design	Interventional
Study design	Non-blind randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Morphine
Primary outcome measure(s)	1. Pain intensity 2. Side-effects 3. Morphine dosage
Key secondary outcome measure(s)	1. Length of treatment 2. Hospital stay 3. Quality of life
Completion date	14/04/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan