The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

147

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

October 31, 2015

Study Completion Date

November 1, 2016

Conditions
Postoperative PainChronic PainAnalgesics
Interventions
DRUG

(S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml

Ketamine (25 mg/ml) bolus 0.5 mg/kg administered immediately after induction of anesthesia, followed by infusion ketamine 0,25 mg/kg/hour that is terminated when the last suture to the skin has been performed.

DRUG

Isotonic sodium chloride 0.9 percent

Isotonic sodium chloride 0.9 percent 0.02 ml/kg administered immediately after induction of anesthesia, followed by infusion isotonic sodium chloride 0.01 ml/kg/hour that is terminated when the last suture to the skin has been performed.

DRUG

Paracetamol 1 g

Paracetamol 1 g orally 1 hour preoperatively and every 6 hours after extubation time during the first 24 hours.

DRUG

Morphine Sulphate 1 mg/ml

Morphine Sulphate 1 mg/ml administered as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 5 minutes) 0-24 hours postoperatively

DRUG

Morphine Sulphate 1 mg/ml

Morphine Sulphate 1 mg/ml, bolus 2.5 mg administered by the PACU nurse on request of the patient for the first hour postoperatively.

DRUG

Ondansetron 2 mg/ml

Ondansetron 2 mg/ml 4 mg iv in case of moderate to severe nausea, supplemented by Ondansetron 1 mg iv if needed

DRUG

Usual daily opioids

The patients usual daily opioid consumption are administered during the study period

DRUG

Morphine Sulphate 1 mg/ml

Morphine Sulphate 1 mg/ml, bolus 0.4 mg/kg administered 45 minutes before expected awakening.

DRUG

Sufentanil 5 microgram/ml

Sufentanil 5 microgram/ml, bolus 5 micrograms administered by the anaesthetic nurse in the operating room if the patient is in pain upon awakening.

Trial Locations (1)

2600

Department of Anaesthesiology, Glostrup Hospital, Glostrup Municipality

All Listed Sponsors
collaborator

Glostrup University Hospital, Copenhagen

OTHER

lead

Rigshospitalet, Denmark

OTHER

NCT02085577 - The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients | Biotech Hunter | Biotech Hunter