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

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 Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Metamizole and Ibuprofen; Drug: Metamizole and Placebo; Drug: Ibuprofen and Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Anesthesia, University of Basel Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Metamizole and Ibuprofen; Metamizole (1000mg) plus Ibuprofen (400mg) 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
Active Comparator: Metamizole and Placebo; This is one of the two comparators for the Arm "Metamizol and Ibuprofen". n=21	Drug: Metamizole and Placebo; Metamizole (1000mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
Active Comparator: Ibuprofen and Placebo; This is the second of the two comparators for the Arm "Metamizol and Ibuprofen". n=21	Drug: Ibuprofen and Placebo; Ibuprofen (400mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	first 12 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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	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	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	total observation period (maximum 18 hours)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Wilhelm Ruppen, PD Dr. med, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2016
• Primary Completion (Actual): April 28, 2021
• Study Completion (Actual): April 28, 2021

Study Registration Dates

• First Submitted: February 16, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Ibuprofen; Dipyrone
• Other Study ID Numbers: EKNZ 2015-284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided