Effect of Perioperative i.v. Low-dose S(+) Ketamine
The purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine reduces the amount and degree of postoperative pain.
Furthermore the purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine effects cognitive function in the early postoperative period.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy|
- NRS Pain = Numeric Rating Scale (0-10) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.
|Study Start Date:||August 2006|
|Study Completion Date:||May 2009|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
|Active Comparator: S (+) Ketamine||
Drug: S (+) Ketamine
0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery
The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that S (+) ketamine can be effective to reduce sensitization and postoperative pain. Ketamine (2-O-chlorophenyl-2-methylamino cyclohexanone) is a N-Methyl-D-Aspartat (NMDA) receptor antagonist. S (+) ketamine has a four times stronger affinity to the NMDA receptor compared to R (-) ketamine. The duration of action for S (+) ketamine is shorter than R (-) ketamine and it has fewer side-effects.
The purpose of this study is to compare the analgetic effect of pregabalin and placebo used in the perioperative period.
The hypothesis is that perioperative intravenous S (+) ketamine gives significant better analgesia than placebo without effecting cognitive function.
The study is including patients undergoing hemorrhoidectomy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354029
|Asker and Baerum Hospital|
|Rud, Norway, N-1309|
|Principal Investigator:||Ulrich J Spreng, Dr. med,||Asker and Baerum Hospital, Norway|
|Study Director:||Vegard Dahl, Dr. med.||Asker and Baerum Hospital, Norway|