No registrations found.
ID
Source
Brief title
Health condition
Complex Regional Pain Syndrome type I (CRPS type I)
Complex Regionaal Pijn Syndroom type I (CRPS type I)
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Pain scores (NRS)
- Allocation scores patients, whether they received S(+)-ketamine or placebo.
Secondary outcome
- Occurence of side effects
- Presence of CRPS type I diagnosis after treatment.
Background summary
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.
Study objective
Multiple rounds of S(+)-ketamine infusions will give more profound and prolonged pain relief compared to a single infusion of S(+)-ketamine.
Study design
- 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.
Intervention
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.
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
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
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1479 |
| NTR-old | NTR1550 |
| Other | TREND, Delft (NL); BSIK03016 : P08.106 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |