|- candidate number||4563|
|- NTR Number||NTR1550|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-nov-2008|
|- Secondary IDs||P08.106 TREND, Delft (NL); BSIK03016|
|- Public Title||Treatment of Complex Regional Pain Syndrome type I; A randomised, single-blind, placebo-controlled study with multiple rounds of S(+)-ketamine infusions.|
|- Scientific Title||Treatment of Complex Regional Pain Syndrome type I; A randomised, single-blind, placebo-controlled study with multiple rounds of S(+)-ketamine infusions.|
|- ACRONYM||The KetKet study, pilot|
|- hypothesis||Multiple rounds of S(+)-ketamine infusions will give more profound and prolonged pain relief compared to a single infusion of S(+)-ketamine.|
|- Healt Condition(s) or Problem(s) studied||Complex Regionaal Pain Syndrome (CRPS), Ketamine |
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2008|
|- planned closingdate||1-nov-2010|
|- Target number of participants||30|
|- Interventions||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.
|- 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.
|- Timepoints||- 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.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. I.M. Noppers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Albert Dahan|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Anaesthesiology|
(Source(s) of Monetary or Material Support)
|TREND Delft |
|- Brief 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.|
|- Main changes (audit trail)|
|- RECORD||20-nov-2008 - 23-aug-2010|