Multiple rounds of S(+)-ketamine infusions will give more profound and prolonged pain relief compared to a single infusion of S(+)-ketamine.
ID
Bron
Verkorte titel
Aandoening
Complex Regional Pain Syndrome type I (CRPS type I)
Complex Regionaal Pijn Syndroom type I (CRPS type I)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Pain scores (NRS)<br>
- Allocation scores patients, whether they received S(+)-ketamine or placebo.
Achtergrond van het onderzoek
The treatment of Complex Regional Pain Syndrome type I (CRPS) with S(+)-ketamine showed good pain relief for weeks. However, in most patients, the pain returns to baseline levels. Open label studies suggest a longer duration of pain relief when ketamine is administered more than once. In this randomised, single-blind, placebo-controlled pilot study, we adminster S(+)-ketamine once or twice to test whether pain relief is prolonged with multiple infusions of S(+)-ketamine.
Doel van het onderzoek
Multiple rounds of S(+)-ketamine infusions will give more profound and prolonged pain relief compared to a single infusion of S(+)-ketamine.
Onderzoeksopzet
- Baseline measurements before first admission.
- Measurements, on average 3 times a day, during admissions.
- Weekly measurements between and after admissions, until baseline is reached, afterwards on average monthly measurements.
- Follow-up up to 52 weeks from first admission.
Onderzoeksproduct en/of interventie
Patients are randomised into 3 groups.
Admissions will take place in week 1 and 4 or week 1 and 13 of the study. All patients are admitted twice for 5 days, during which they will receive intravenous S(+)-ketamine or active placebo midazolam, both in an increasing subanesthetic dose based on weight.
Algemeen / deelnemers
Department of Anaesthesiology <br>
P.O. Box 9600
I.M. Noppers
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
i.m.noppers@lumc.nl
Wetenschappers
Department of Anaesthesiology <br>
P.O. Box 9600
I.M. Noppers
Leiden 2300 RC
The Netherlands
+31 (0)71 5262301
i.m.noppers@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. CRPS type I diagnosis according to the IASP-criteria;
2. NRS spontaneous pain score of 5 or higher;
3. Age is between 18 and 70 years;
4. Patients must give a written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients who are not able to give informed consent;
2. Patients suffering from other syndromes/diseases interfering with pain ratings;
3. Patients who previous have had ketamine continuous infusion;
4. Patients with co-morbidity such as:
kidney disease, severe liver disease, nerve damage in the affected area, increased intracranial pressure, infectious disease, epilepsy, a psychiatric illness, thyroid disease, cancer, cardiac disease, pulmonary disease, severe or uncontrolled hypertension, aneurysm, glaucoma, history of cerebral vascular accident (CVA) < 1 year;
5. Patients who are pregnant.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL1479 |
NTR-old | NTR1550 |
Ander register | TREND, Delft (NL); BSIK03016 : P08.106 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |