Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction (NovIbu)

University Hospital Basel

Status and phase

Completed

Phase 4

Conditions

Pain, Postoperative

Treatments

Drug: Metamizole and Placebo

Drug: Ibuprofen and Placebo

Drug: Metamizole and Ibuprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT02686021

EKNZ 2015-284

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

36 participants in 3 patient groups

Metamizole and Ibuprofen

Experimental group

Description:

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).

Treatment:

Drug: Metamizole and Ibuprofen

Metamizole and Placebo

Active Comparator group

Description:

This is one of the two comparators for the Arm "Metamizol and Ibuprofen". n=21

Treatment:

Drug: Metamizole and Placebo

Ibuprofen and Placebo

Active Comparator group

Description:

This is the second of the two comparators for the Arm "Metamizol and Ibuprofen". n=21