The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery

PHASE4CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

September 30, 2015

Conditions
Pain
Interventions
DRUG

Dexamethasone

Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation

OTHER

Placebo

Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation

DRUG

Morphine

Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.

DRUG

Zofran

Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed

DRUG

Paracetamol

Tablet Paracetamol 1 g orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.

DRUG

Ibuprofen

Tablet Ibuprofen 400 mg orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.

Trial Locations (1)

2600

Glostrup University Hospital, Glostrup Municipality

All Listed Sponsors
collaborator

Glostrup University Hospital, Copenhagen

OTHER

lead

Rigshospitalet, Denmark

OTHER

NCT01953978 - The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery | Biotech Hunter | Biotech Hunter