Pain, Postoperative
Conditions
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.
Interventions
DRUGMetamizole and Ibuprofen
Metamizole (1000mg) plus Ibuprofen (400mg) 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
DRUGMetamizole and Placebo
Metamizole (1000mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
Ibuprofen (400mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Switzerland
Outcome results
None listed