search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Patient controlled analgesia versus continuous infusion of morphine during vaso-occlusive crisis in sickle cell disease, a randomized controlled trial.


- candidate number2058
- NTR NumberNTR647
- ISRCTNISRCTN74336585
- Date ISRCTN created28-apr-2006
- date ISRCTN requested25-apr-2006
- Date Registered NTR12-apr-2006
- Secondary IDsN/A 
- Public TitlePatient controlled analgesia versus continuous infusion of morphine during vaso-occlusive crisis in sickle cell disease, a randomized controlled trial.
- Scientific TitlePatient controlled analgesia versus continuous infusion of morphine during vaso-occlusive crisis in sickle cell disease, a randomized controlled trial.
- ACRONYMN/A
- hypothesisThe 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) studiedSickle cell disease
- Inclusion criteria1. 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 criteria1. Patients already recieving opioids for more than 24 hours at time of randomization;
2. Allergy or intolerance for morphine;
3. Pregnancy;
4. Chronic use of opinoids.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 4-okt-2004
- planned closingdate14-apr-2005
- Target number of participants25
- InterventionsPatient controlled analgesia versus continuous infusion of morphine.
- Primary outcome1. Pain intensity;
2. Side-effects;
3. Morphine dosage.
- Secondary outcome1. Lenght of treatment;
2. Hospital stay;
3. Quality of life.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. B.J. Biemond
- CONTACT for SCIENTIFIC QUERIESDr. B.J. Biemond
- Sponsor/Initiator Academic Medical Center (AMC), Department of Heamatology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsAm J Hematol. 2007 Nov;82(11):955-60.
- Brief summaryObjective:
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.


Design:
Non-blind randomised controlled trial.


Setting:
Tertiary referral centre.


Subjects:
Patients with SCD admitted with vaso-occlusive crisis.


Interventions:
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.


Results:
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)
- RECORD12-apr-2006 - 2-jul-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl