|- candidate number||2058|
|- NTR Number||NTR647|
|- Date ISRCTN created||28-apr-2006|
|- date ISRCTN requested||25-apr-2006|
|- Date Registered NTR||12-apr-2006|
|- Secondary IDs||N/A |
|- Public Title||Patient controlled analgesia versus continuous infusion of morphine during vaso-occlusive crisis in sickle cell disease,
a randomized controlled trial.|
|- Scientific Title||Patient controlled analgesia versus continuous infusion of morphine during vaso-occlusive crisis in sickle cell disease,
a randomized controlled trial.|
|- 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 randomized trial. In addition, quality of life and the effect on the duration of treatment and hospitalization will be determined. |
|- Healt Condition(s) or Problem(s) studied||Sickle cell disease|
|- Inclusion criteria||1. Sickle cell disease defined as HbSS, HbSC or HbSâ (by electropheresis);|
2. Age > 17 years;
3. The presence of typical pain recognized by patients as originating from vaso-occlusive crisis and which can not be explained by other causes;
4. Severe pain necessitating treatment with intravenous morphine;
5. Written informed consent.
|- Exclusion criteria||1. Patients already recieving opioids for more than 24 hours at time of randomization;|
2. Allergy or intolerance for morphine;
4. Chronic use of opinoids.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||4-okt-2004|
|- planned closingdate||14-apr-2005|
|- Target number of participants||25|
|- Interventions||Patient controlled analgesia versus continuous infusion of morphine.|
|- Primary outcome||1. Pain intensity;|
3. Morphine dosage.
|- Secondary outcome||1. Lenght of treatment;|
2. Hospital stay;
3. Quality of life.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. B.J. Biemond|
|- CONTACT for SCIENTIFIC QUERIES||Dr. B.J. Biemond|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Heamatology|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Publications||Am J Hematol. 2007 Nov;82(11):955-60.|
|- Brief summary||Objective:|
To measure the efficacy of intravenous morphine administration with patient controlled analgesia compared with continuous infusion of morphine in patients with sickle cell disease (SCD) during vaso-occlusive crisis on pain, morphine dosage, and side-effects.
Non-blind randomised controlled trial.
Tertiary referral centre.
Patients with SCD admitted with vaso-occlusive crisis.
Patient controlled analgesia (PCA-group) versus continuous infusion of morphine (CI-group).
Main outcome measures:
Pain intensity and symptoms of side-effects were measured four times per day on a 11-point numerical rating scale. Area under the curve for symptoms of side-effects during treatment, mean hourly and total morphine dosage, and mean pain score were main outcomes.
Twenty five consecutive episodes of vaso-occlusive crisis with SCD were included in the study. Patients in the PCA-group had a markedly and significant lower mean and cumulative morphine consumption as compared to those in the CI-group (0.5 mg/h versus 2.4 mg/h (P<0.001) and 33 mg versus 260 mg (P=0.018) respectively) and a non-significant reduction in the duration of hospital admission of 3 days. The mean daily pain scores were comparable (4.9 versus 5.3). The lower mean and cumulative morphine consumption in the PCA-group led to significant lower cumulative side-effect-scores for nausea and constipation during treatment compared to the CI-group (area under the curve respectively 11 versus 18 (P= 0.045) and 30 versus 45 (P= 0.021).
Conclusion Patient controlled analgesia may be first choice in morphine administration in patients admitted with vaso-occlusive crisis.
|- Main changes (audit trail)|
|- RECORD||12-apr-2006 - 2-jul-2008|