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…
ID
Bron
Verkorte titel
Aandoening
Vaso-occlusive crisis in sickle cell disease.
Ondersteuning
Department of Heamatology.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Pain intensity;<br>
2. Side-effects;<br>
3. Morphine dosage.<br>
Achtergrond van het onderzoek
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.
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patient controlled analgesia versus continuous infusion of morphine.
Publiek
P.O. Box 22660
B.J. Biemond
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667391
b.j.biemond@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
B.J. Biemond
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667391
b.j.biemond@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL591 |
| NTR-old | NTR647 |
| Ander register | : N/A |
| ISRCTN | ISRCTN74336585 |