drugset / Trial / NCT01953978
The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery
Phase 4
Completed
160 enrolled
Rigshospitalet, Denmark
Glostrup University Hospital, Copenhagen · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2012-12
- Primary completion
- 2014-08
- Completion
- 2015-09
Publications
- Nielsen RV, Fomsgaard J, Mathiesen O, Dahl JB. The effect of preoperative dexamethasone on pain 1 year after lumbar disc surgery: a follow-up study. BMC Anesthesiol. 2016 Nov 16;16(1):112. doi: 10.1186/s12871-016-0277-z.
- Nielsen RV, Siegel H, Fomsgaard JS, Andersen JDH, Martusevicius R, Mathiesen O, Dahl JB. Preoperative dexamethasone reduces acute but not sustained pain after lumbar disk surgery: a randomized, blinded, placebo-controlled trial. Pain. 2015 Dec;156(12):2538-2544. doi: 10.1097/j.pain.0000000000000326.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 16 mg | Intravenous |
| Comparator | Acetaminophen | Small molecule | 1 g | Oral |
| Comparator | Ibuprofen | Small molecule | 400 mg | Oral |
| Comparator | Morphine | Other / unclassified | 2.5 mg | Intravenous |
| Comparator | Ondansetron | Other / unclassified | 4 mg | Intravenous |
Indications
No indication recorded.