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)


Treatment of Complex Regional Pain Syndrome type I; A randomised, single-blind, placebo-controlled study with multiple rounds of S(+)-ketamine infusions.


- candidate number4563
- NTR NumberNTR1550
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-nov-2008
- Secondary IDsP08.106 TREND, Delft (NL); BSIK03016
- Public TitleTreatment of Complex Regional Pain Syndrome type I; A randomised, single-blind, placebo-controlled study with multiple rounds of S(+)-ketamine infusions.
- Scientific TitleTreatment of Complex Regional Pain Syndrome type I; A randomised, single-blind, placebo-controlled study with multiple rounds of S(+)-ketamine infusions.
- ACRONYMThe KetKet study, pilot
- hypothesisMultiple 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) studiedComplex Regionaal Pain Syndrome (CRPS), Ketamine
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2008
- planned closingdate1-nov-2010
- Target number of participants30
- InterventionsPatients 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 siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESDrs. I.M. Noppers
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Anaesthesiology
- Funding
(Source(s) of Monetary or Material Support)
TREND Delft
- PublicationsN/A
- Brief summaryThe 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)
- RECORD20-nov-2008 - 23-aug-2010


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