The Preemptive Analgetic Potency of Low Dose S-Ketamine

Pain Clinical Trial

— Miniket  

Official title:

The Opioid Sparing Effect of Minimal Dose S-Ketamine Applied as a Coanalgesic During the Perioperative Period - An Active Placebo-Controlled, Double Blinded, Randomized Clinical Trial (МiniKet)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022840
• Other study ID #: 180808
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2009
• Last updated: October 1, 2012
• Start date: February 2009
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The primary hypothesis is improved postoperative analgetic quality using S-Ketamine, particularly in patients suffering from chronic pain.

Description:

The investigators are dealing mainly with the finding of the right dosage for the optimal safety and efficacy of S-Ketamine, but also discovering new possible areas of investigation (e.g. anti-depressive effect, anti-neuropathic effect).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for major abdominal surgery

• Suitable for PCA

• Cardio-vascular stable

• Age: 18+

• Between 50-120kg BW

• ASA 1-3

• Good Compliance for pain monitoring

Exclusion Criteria:

• Allergy to S-Ketamine

• Severe liver or kidney dysfunction

• Severe coronary disease

• Pregnancy

• Present or past psychotic disorders

• Addiction to alcohol or opioids

• Poor compliance

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• S-Ketamine
drug

Other:
• Placebo Comparison
saline control

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz	Styria
Austria	Medical University of Graz	Graz	Styria
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative opioid consumption		1 year	Yes