Effect of Perioperative i.v. Low-dose S(+) Ketamine

Phase 4

Completed

• Conditions: Hemorrhoids; Pain
• Interventions: Drug: Placebo; Drug: S (+) Ketamine

• Registration Number: NCT00354029
• Lead Sponsor: Asker & Baerum Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2006-07-18
• Study First Submitted QC: 2006-07-18
• Study First Posted: 2006-07-19
• Study Start: 2006-08
• Primary Completion: 2008-06
• Study Completion: 2009-05
• Results First Submitted: 2011-05-24
• Status Verified: 2011-07
• Results First Submitted QC: 2011-07-19
• Last Update Submitted: 2011-07-19
• Results First Posted: 2011-07-20
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Clinical diagnosis of disc prolapse
• Age 18+
• ASA (American Society in Anesthesiology) I-II
• written consent

Exclusion Criteria

• Age < 18
• ASA > II
• liver failure
• renal failure
• heart failure
• glaucoma
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline 0,9%
S (+) Ketamine	S (+) Ketamine	-

Primary Outcome Measures

Name	Time	Method
NRS Pain = Numeric Rating Scale (0-10)	24 hours	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.

Trial Locations

Locations (1)

Asker and Baerum Hospital; 🇳🇴 Rud, Norway