The Preemptive Analgetic Potency of Low Dose S-Ketamine (Miniket)

Medical University of Graz

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: S-Ketamine; Other: Placebo Comparison

Study type: Interventional

Funder types: Other

Identifiers

NCT01022840

180808

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo as saline solution

Treatment:

Other: Placebo Comparison

Low dose

Experimental group

Description:

S-Ketamine

Treatment:

Drug: S-Ketamine

High dose

Active Comparator group

Treatment:

Drug: S-Ketamine