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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21045
Enrollment
30
Registered
2008-11-20
Start date
2008-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome type I (CRPS type I) Complex Regionaal Pijn Syndroom type I (CRPS type I)

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

Sponsors

Leiden University Medical Center (LUMC), Department of Anesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
- Pain scores (NRS) - Allocation scores patients, whether they received S(+)-ketamine or placebo.

Secondary

MeasureTime frame
- Occurence of side effects - Presence of CRPS type I diagnosis after treatment.

Contacts

Public ContactI.M. Noppers

Leiden University Medical Center (LUMC) Department of Anaesthesiology P.O. Box 9600

i.m.noppers@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)