Contact information
Type
Scientific
Primary contact
Dr M.J. Sigtermans
ORCID ID
Contact details
Leiden University Medical Center
Department of Anaesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5262301
m.j.sigtermans@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR507; LUMC P05.100; Min. of Econ. Aff., BSIK03016
Study information
Scientific title
Acronym
Study hypothesis
S(+)-ketamine reduces pain in patients with Complex Regional Pain Syndrome type 1 having symptoms shorter than 6 months and longer than 3 years.
Ethics approval
Received from local medical ethics committee
Study design
Randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Complex regional pain syndrome type 1 (CRPS I)
Intervention
Subjects are assigned to receive either intravenous (S+)-ketamine or placebo.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Pain reduction measured by numerical rating scale (0 no pain, 10 worst imaginable pain).
Secondary outcome measures
Secondary aims of the study deal with:
1. The role of NMDA receptor activation in the autonomic and motor features of CRPS
2. To establish the endurance of ketamine on the impairments of CRPS
3. To study the pharmacokinetics and pharmacodynamics of ketamine in subanaesthetic doses
4. To establish data for future pragmatic studies on ketamine iv in patients with CRPS on the levels of disability and safety
Overall trial start date
01/12/2005
Overall trial end date
01/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients will be male or female adult patients with a clinical diagnosis of CRPS 1 who are referred to the pain centre outpatients' clinic of the department of Anaesthesiology at the LUMC.
1. Patients should fulfill the diagnostic criteria of the consensus report of CRPS 1:
1.1. Continuing pain, allodynia or hyperalgesia, in which the pain is disproportionate to any inciting event
1.2. Evidence at some time of edema, changes in skin blood flow or abnormal sudomotor activity in the region of the pain
1.3. No condition that would otherwise account for the degree of pain and dysfunction
2. Patients must report a VAS-spontaneous pain score of 5 cm or higher
3. Patient's age is between 18 and 70 years
4. Onset of symptoms must be shorter than 6 months or longer than 3 years before inclusion
5. Patients should give a written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Patients who are not able to give informed consent
2. Patients suffering from other pain syndromes, interfering with pain ratings
3. Patients suffering from other syndromes interfering with pain ratings
4. Patients suffering from a kidney and/or severe liver disease
5. Patients suffering from nerve damage in the affected area
6. Patients with an active infection
7. Patients with high intracranial pressure
8. Patients with epilepsy
9. Patients with a psychiatric illness
10. Patients with thyroid disease
11. Patients with cancer
12. Patients with cardiac disease
13. Patients with pulmonary disease
14. Patients with glaucoma
15. Patients with a history of cerebral vascular accident (CVA)
16. Patients who are a pregnant
17. Strong-opioid consumption (step one and two of the WHO pain ladder is allowed)
Recruitment start date
01/12/2005
Recruitment end date
01/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
Funders
Funder type
Government
Funder name
Ministry of Economic Affairs (Netherlands)
Alternative name(s)
Ministry of Economic Affairs, Netherlands Ministry of Economic Affairs, EZ
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19604642
Publication citations
-
Results
Sigtermans MJ, van Hilten JJ, Bauer MC, Arbous MS, Marinus J, Sarton EY, Dahan A, Ketamine produces effective and long-term pain relief in patients with Complex Regional Pain Syndrome Type 1., Pain, 2009, 145, 3, 304-311, doi: 10.1016/j.pain.2009.06.023.