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

Pain, Postoperative Clinical Trial

— NovIbu  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686021
• Other study ID #: EKNZ 2015-284
• Status: Completed
• Phase: Phase 4
• Start date: February 15, 2016
• Est. completion date: April 28, 2021

Study information

• Verified date: May 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Anesthesia, University of Basel Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)