Pain, PostoperativePhase 4NovIbuNCT02686021
Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction
A Phase 4 study testing Metamizole and Ibuprofen in people with Pain, Postoperative, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Metamizole and Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Feb 2016to 28 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anesthesia, University of Basel Hospital
Basel, 4031
About this study
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.
- Conditions
- Pain, Postoperative
- Being tested
- Metamizole and Ibuprofen, Metamizole and Placebo, Ibuprofen and Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Metamizole and Ibuprofen | Experimental | 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). Receives: Drug: Metamizole and Ibuprofen |
| Metamizole and Placebo | Active comparator | This is one of the two comparators for the Arm "Metamizol and Ibuprofen". n=21 Receives: Drug: Metamizole and Placebo |
| Ibuprofen and Placebo | Active comparator | This is the second of the two comparators for the Arm "Metamizol and Ibuprofen". n=21 Receives: Drug: Ibuprofen and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: first 12 postoperative hours
Secondary outcomes (5)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: total observation period (maximum 18 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study start15 Feb 2016
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilhelm Ruppen, PD Dr. med, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686021
- Sponsor's protocol ID
- EKNZ 2015-284
- Acronym
- NovIbu
- Status last verified
- May 2021
- First submitted
- 16 Feb 2016
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction
- ClinicalTrials.gov ID
- NCT02686021
- Acronym / sponsor ID
- NovIbu / EKNZ 2015-284
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metamizole and Ibuprofen | Experimental | Drug: Metamizole and Ibuprofenall 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). |
| Metamizole and Placebo | Active comparator | Drug: Metamizole and PlaceboThis is one of the two comparators for the Arm "Metamizol and Ibuprofen". n=21 |
| Ibuprofen and Placebo | Active comparator | Drug: Ibuprofen and PlaceboThis is the second of the two comparators for the Arm "Metamizol and Ibuprofen". n=21 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metamizole and IbuprofenMetamizole (1000mg) plus Ibuprofen (400mg) 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours | Drug | Metamizole and Ibuprofen |
| Metamizole and PlaceboMetamizole (1000mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours | Drug | Metamizole and Placebo |
| Ibuprofen and PlaceboIbuprofen (400mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours | Drug | Ibuprofen and Placebo |
Primary outcome
area under the curve for pain in the first 12 postoperative hours
Time frame: 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
5 secondary outcomes
area under the curve for pain in the first 18 postoperative hours
Time frame: first 18 postoperative hours
highest pain score
Time frame: total observation period (maximum 18 hours)
night time pain
Time frame: first night after the intervention
need for and timing of rescue medication
Time frame: total observation period (maximum 18 hours)
haemorrhage requiring intervention
Time frame: total observation period (maximum 18 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilhelm Ruppen, PD Dr. med principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metamizole and Ibuprofen in people with Pain, Postoperative, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area under the curve for pain in the first 12 postoperative hours (time frame: first 12 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.