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

University Hospital, Basel, Switzerland36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Postoperative

Interventions

Metamizole and IbuprofenDRUG

Metamizole (1000mg) plus Ibuprofen (400mg) 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours

Metamizole and PlaceboDRUG

Metamizole (1000mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours

Ibuprofen and PlaceboDRUG

Ibuprofen (400mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesia, University of Basel Hospital

Basel, Switzerland

Outcomes

Primary Outcomes

area under the curve for pain in the 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

Time frame: first 12 postoperative hours

Secondary Outcomes

area under the curve for pain in the 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)

Time frame: first 18 postoperative hours

highest pain score

This secondary outcome is the highest pain score registered during the observation period, as assessed by the numeric rating scale

Time frame: total observation period (maximum 18 hours)

night time pain

This secondary outcome is the overall pain during the first night after the intervention, as assessed by the numeric rating scale

Time frame: first night after the intervention

need for and timing of rescue medication

This secondary outcome is the marked "yes" or "no", depending on whether a rescue medication (extra pain medication) was needed or not

Time frame: total observation period (maximum 18 hours)

haemorrhage requiring intervention

This secondary outcome is the marked "yes" or "no", depending on whether an intervention to stop haemorrhage was needed or not

Time frame: total observation period (maximum 18 hours)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.