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

Summary

The analgesic effect of dexamethasone is not well described, but studies have shown that dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.

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.

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Rikke Soennichsen, MD · Glostrup University Hospital

• Joergen B Dahl, MD · Rigshospitalet, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2014-08-31

Completion

2015-09-30

Countries

• Denmark

Study Locations