Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction
- Conditions
- Pain, Postoperative
- Interventions
- Registration Number
- NCT02686021
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
Postoperative pain is common and particularly outpatients may experience unsatisfactory pain relief. This randomized, double-blind, crossover study of postoperative pain in outpatients undergoing split-mouth, third lower molar extraction aims to examine whether or not the combination of metamizole and ibuprofen is superior to either drug alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- planned sequential both-sided lower third molar extraction (split-mouth) with osteotomy (with or without upper molar extraction in local anesthesia)
- able to understand the study and the NRS scale
- simultaneous both sided extraction or only upper third molar extraction
- general anesthesia
- known or presumed abnormal coagulation status
- known or presumed liver or renal dysfunction
- contraindication against metamizole known or suspected (known or suspected allergy against novalgin or other pyrazolones, anaphylactic reaction against NSAIDS, decreased bone marrow function or hematopoesis, hepatic porphyria, glucose-6-phosphate dehydrogenase deficiency, and pregnancy/breastfeeding)
- contraindication against ibuprofen (known or suspected allergy against ibuprofen, anaphylactic reaction against Nonsteroidal anti-inflammatory drugs (NSAID), active or recurrent stomach or duodenal ulcera or bleeding, severe liver or renal insufficiency, inflammatory bowel syndrome, and pregnancy/breastfeeding)
- pregnancy and breast feeding mothers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Metamizole and Placebo Metamizole and Placebo This is one of the two comparators for the Arm "Metamizol and Ibuprofen". n=21 Ibuprofen and Placebo Ibuprofen and Placebo This is the second of the two comparators for the Arm "Metamizol and Ibuprofen". n=21 Metamizole and Ibuprofen Metamizole and Ibuprofen all patients (n=42) will receive metamizol and ibuprofen in one session. In the other session half will receive metamizol and placebo (n=21) and the other half will receive ibuprofen and placebo. The order will be randomized (balanced).
- Primary Outcome Measures
Name Time Method area under the curve for pain in the first 12 postoperative hours first 12 postoperative hours The primary outcome is the area under the curve for pain in the first 12 postoperative hours, as assessed by the numeric rating scale
- Secondary Outcome Measures
Name Time Method area under the curve for pain in the first 18 postoperative hours first 18 postoperative hours This secondary outcome is the area under the curve for pain in the first 18 postoperative hours, as assessed by the numeric rating scale (NRS)
night time pain first night after the intervention This secondary outcome is the overall pain during the first night after the intervention, as assessed by the numeric rating scale
highest pain score total observation period (maximum 18 hours) This secondary outcome is the highest pain score registered during the observation period, as assessed by the numeric rating scale
haemorrhage requiring intervention total observation period (maximum 18 hours) This secondary outcome is the marked "yes" or "no", depending on whether an intervention to stop haemorrhage was needed or not
need for and timing of rescue medication total observation period (maximum 18 hours) This secondary outcome is the marked "yes" or "no", depending on whether a rescue medication (extra pain medication) was needed or not
Trial Locations
- Locations (1)
Department of Anesthesia, University of Basel Hospital
🇨🇭Basel, Switzerland