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

Pain Clinical Trial

Official title:

Effect of Perioperative i.v. Low-dose S(+) Ketamine in Patients Undergoing Hemorrhoidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354029
• Other study ID #: 2006-001082-41
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2006
• Last updated: July 19, 2011
• Start date: August 2006
• Est. completion date: May 2009

Study information

• Verified date: July 2011
• Source: Asker & Baerum Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids
• Pain

Intervention

Drug:
• S (+) Ketamine
0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery
• Placebo
isotonic saline

Locations

Country	Name	City	State
Norway	Asker and Baerum Hospital	Rud

Sponsors (1)

Lead Sponsor	Collaborator
Asker & Baerum Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Arendt-Nielsen L, Nielsen J, Petersen-Felix S, Schnider TW, Zbinden AM. Effect of racemic mixture and the (S+)-isomer of ketamine on temporal and spatial summation of pain. Br J Anaesth. 1996 Nov;77(5):625-31. — View Citation

Bell RF, Dahl JB, Moore RA, Kalso E. Peri-operative ketamine for acute post-operative pain: a quantitative and qualitative systematic review (Cochrane review). Acta Anaesthesiol Scand. 2005 Nov;49(10):1405-28. Review. — View Citation

Himmelseher S, Durieux ME. Ketamine for perioperative pain management. Anesthesiology. 2005 Jan;102(1):211-20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS Pain = Numeric Rating Scale (0-10)	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.	24 hours	No