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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Metamizole and Ibuprofen
Metamizole and Placebo
Ibuprofen and Placebo
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Anesthesia, University of Basel Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Metamizole and Ibuprofen

Metamizole and Placebo

Ibuprofen and Placebo

Arm 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).

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
highest pain score
This secondary outcome is the highest pain score registered during the observation period, as assessed by the numeric rating scale
night time pain
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
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
This secondary outcome is the marked "yes" or "no", depending on whether an intervention to stop haemorrhage was needed or not

Full Information

First Posted
February 16, 2016
Last Updated
May 3, 2021
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02686021
Brief Title
Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction
Acronym
NovIbu
Official Title
Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metamizole and Ibuprofen
Arm Type
Experimental
Arm 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).
Arm Title
Metamizole and Placebo
Arm Type
Active Comparator
Arm Description
This is one of the two comparators for the Arm "Metamizol and Ibuprofen". n=21
Arm Title
Ibuprofen and Placebo
Arm Type
Active Comparator
Arm Description
This is the second of the two comparators for the Arm "Metamizol and Ibuprofen". n=21
Intervention Type
Drug
Intervention Name(s)
Metamizole and Ibuprofen
Intervention Description
Metamizole (1000mg) plus Ibuprofen (400mg) 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
Intervention Type
Drug
Intervention Name(s)
Metamizole and Placebo
Intervention Description
Metamizole (1000mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
Intervention Type
Drug
Intervention Name(s)
Ibuprofen and Placebo
Intervention Description
Ibuprofen (400mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
Primary Outcome Measure Information:
Title
area under the curve for pain in the first 12 postoperative hours
Description
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 Outcome Measure Information:
Title
area under the curve for pain in the first 18 postoperative hours
Description
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
Title
highest pain score
Description
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)
Title
night time pain
Description
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
Title
need for and timing of rescue medication
Description
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)
Title
haemorrhage requiring intervention
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilhelm Ruppen, PD Dr. med
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia, University of Basel Hospital
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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