PainPhase 4NCT02730026
Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole in Lower Third Molar Removal
A Phase 4 study testing Ketoprofen and Ketoprofen and Omeprazole in people with Pain and Other Surgical Procedures, run by Luis Fernando Simoneti at 1 site in Brazil.
Trial summary
The control of pain, swelling and trismus in patients undergoing oral and maxillofacial surgery is frequently performed through the administration of non-steroidal anti-inflammatory drugs (NSAIDS). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Other Surgical Procedures
- What is being tested?
- Ketoprofen and Ketoprofen and Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Mar 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Need of lower third molar surgeries in similar positions
Who cannot join
- Presence of systemic diseases;
- Presence of local inflammation and/or infection;
- Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration;
- Cardiovascular, kidney or hepatic diseases;
- Patients who are making use of antidepressants, diuretics or anticoagulants;
- Asthma and allergy to aspirin, naproxen or any other nonsteroidal antiinflammatory drug;
- Regular use of any nonsteroidal antiinflammatory drug, pregnancy or breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole, in the Control of Pain, Swelling and Trismus in Lower Third Molar Removal
The control of pain, swelling and trismus in patients undergoing oral and maxillofacial surgery is frequently performed through the administration of non-steroidal anti-inflammatory drugs (NSAIDS). The present study aims to evaluate in a double blind, randomized and crossover manner the clinical efficacy of ketoprofen (immediate release - 100 mg) and ketoprofen in association with omeprazole (modified release - 200 mg ketoprofen with 20 mg omeprazole) in 50 patients aged 18 years or older that require removal of both lower third molars symmetrically positioned. After collection, data will be analyzed by means of graphs and tables to allow the appropriate analyses. Paired t-test will be used to compare the duration of surgeries. Nonparametric Wilcoxon test will be used for the analysis of "rescue medication" and postoperative pain parameters (visual analog scale). Data of "mouth opening" and "swelling" will be statistically analyzed through analysis of variance (ANOVA) followed by Tukey's test for multiple comparisons. Statistical significance will be set at 5%. Results will be presented as mean ± standard deviation of the mean.
Read the detailed description
Studies have shown that NSAIDS exert their therapeutic effect by the inhibition of cyclooxigenases (COX) 1 and 2, which determines the inhibition of prostaglandins production whose effects potentiate the action of many inflammatory mediators. The protocol for the administration of these formulations will involve the administration of a tablet of the immediate release product (100 mg) every 12 hours, and one capsule of the modified release product (200 mg ketoprofen with omeprazole) every 24 hours, during 4 days.
The following parameters will be analyzed:
- subjective postoperative pain evaluation, with the aid of a visual analogue scale,
- mouth opening before the surgery, on the 2nd and 7th postoperative days (moment of suture removal),
- beginning and duration of the surgery after anesthetic administration,
- incidence, type and severity of adverse reactions,
- total amount of rescue analgesic medication (paracetamol),
- facial swelling measured on the 2nd and 7th postoperative days (in comparison with the measurements before the surgery).
- Conditions
- Pain, Other Surgical Procedures
- Being tested
- Ketoprofen, Ketoprofen and Omeprazole
- Keywords
- Ketofrofen, Omeprazole, Lower Third Molar, Oral Surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoprofenDrug
Also called Lower third molar surgery with Ketoprofen
Clinical efficacy of the Ketoprofen 100 mg was study after lower third molar surgery.
Ketoprofen and OmeprazoleDrug
Also called Lower third molar surgery with Ketoprofen and Omeprazole
Clinical efficacy of the Ketoprofen 200 mg and Omeprazole 20 mg will be study after lower third molar surgery.
| Study group | Role | What they receive |
|---|---|---|
| Surgery with Ketoprofen | Experimental | Fifty healthy volunteers underwent removal one of lower third molar, will be treated to control pain, swelling and trismus with ketoprofen 100 mg Receives: Drug: Ketoprofen |
| Surgery with Ketoprofen and Omeprazole | Experimental | Fifty healthy volunteers underwent removal the other lower third molars, will be treated to control pain, swelling and trismus with ketoprofen 200 mg associated with Omeprazole 20 mg Receives: Drug: Ketoprofen and Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective evaluation of postsurgical pain
Subjective evaluation of postsurgical pain, which was annotated by the volunteer, a Visual Analogue Scale (VAS, 0-100 mm) at the fourth postoperative hour.
Measured: Fourth postoperative hour
Quality of anesthesia during surgery based on a category 3point scale
Quality of anesthesia during surgery based on a category 3point scale: 1) the patient reported no discomfort; 2) the patient reported discomfort, without the need to supplement the anesthesia; 3) reported some discomfort by the patient, requiring anesthesia complementation. Intraoral bleeding that will be evaluated by the surgeon according to a 3point scale (1: minimal, 2: normal and 3: Maximum), immediately after the following steps: injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing.
Measured: During the surgical procedure
Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale
Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale (1 minimal bleeding; 2 normal bleeding; 3 excessive bleeding) (SISK, 1986), immediately after the following steps: injection of the first cartridge of articaine, tissue incision, flap reflection, bone removal (when this procedure was necessary), tooth extraction, cleaning of the operated site, and completion of suturing.
Measured: During the surgical procedure
Heart rate
Median heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters
Measured: During the surgical procedure
Oxygen saturation
Median oxygen saturation recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
Measured: During the surgical procedure
Systolic blood pressure
Median systolic blood pressure to be verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters
Measured: During the surgical procedure
Diastolic blood pressure
Median diastolic blood pressure to be verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters
Measured: During the surgical procedure
Secondary outcomes (5)
Mouth opening (mm) between the mesial-incisal corners of the upper and lower right central incisors at maximum opening of the jaws
Mouth opening (mm) between the mesial-incisal corners of the upper and lower right central incisors at maximum opening of the jaws was measured and recorded before the surgery and during the second and seventh postoperative days.
Measured: Second and Seventh postoperative days
Onset and duration of surgery after administration of anesthetic
Will only be considered those surgeries in which there is no long time gap between the two surgical times.
Measured: During the surgery
Incidence, type and severity of adverse reactions
Will be considered as adverse reactions: gastrointestinal irritation, nausea, vomiting, bleeding, allergy, headache, dizziness, drowsiness or any other type of reaction presented after surgery.
Measured: Seventh postoperative day
Total amount of rescue medication
The total amount of rescue medication that was used by the patient during the postoperative period (paracetamol 750 mg) will be analyzed
Measured: Seventh postoperative day
Measurement the facial edema distance between the lateral corner of the eye and the gonion, away from the tragus corner of the mouth and away from the tragus to the soft tissue of pogonion.
It will apply the method used by Ustun et al. (2003), which takes into account the sum of the following measures (obtained with flexible tape measure): A) distance between the lateral corner of the eye and the gonion, B) away from the tragus corner of the mouth and C) away from the tragus to the soft tissue of pogonion. Preoperative sum of three measures will be considered as the baseline that way. The difference between the values obtained in the postoperative period and baseline indicate the facial edema in the 2nd and 7th days.
Measured: On the second day after surgery and on the seventh day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luis Fernando Simoneti
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor-investigator, Luis Fernando Simoneti, University of Sao Paulo
- Investigators
- Luis Fernando Simoneti, DDS, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730026
- Sponsor's protocol ID
- 44808215.6.0000.5417
- Status last verified
- Mar 2017
- First submitted
- 10 Sep 2015
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole, in the Control of Pain, Swelling and Trismus in Lower Third Molar Removal
- ClinicalTrials.gov ID
- NCT02730026
- Acronym / sponsor ID
- 44808215.6.0000.5417
- Conditions
- Pain, Other Surgical Procedures
- Keywords
- Ketofrofen, Omeprazole, Lower Third Molar, Oral Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Luis Fernando SimonetiUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Apr 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.
The control of pain, swelling and trismus in patients undergoing oral and maxillofacial surgery is frequently performed through the administration of non-steroidal anti-inflammatory drugs (NSAIDS). The present study aims to evaluate in a double blind, randomized and crossover manner the clinical efficacy of ketoprofen (immediate release - 100 mg) and ketoprofen in association with omeprazole (modified release - 200 mg ketoprofen with 20 mg omeprazole) in 50 patients aged 18 years or older that require removal of both lower third molars symmetrically positioned. After collection, data will be analyzed by means of graphs and tables to allow the appropriate analyses. Paired t-test will be used to compare the duration of surgeries. Nonparametric Wilcoxon test will be used for the analysis of "rescue medication" and postoperative pain parameters (visual analog scale). Data of "mouth opening" and "swelling" will be statistically analyzed through analysis of variance (ANOVA) followed by Tukey's test for multiple comparisons. Statistical significance will be set at 5%. Results will be presented as mean ± standard deviation of the mean.
Detailed description
Studies have shown that NSAIDS exert their therapeutic effect by the inhibition of cyclooxigenases (COX) 1 and 2, which determines the inhibition of prostaglandins production whose effects potentiate the action of many inflammatory mediators. The protocol for the administration of these formulations will involve the administration of a tablet of the immediate release product (100 mg) every 12 hours, and one capsule of the modified release product (200 mg ketoprofen with omeprazole) every 24 hours, during 4 days.
The following parameters will be analyzed:
- subjective postoperative pain evaluation, with the aid of a visual analogue scale,
- mouth opening before the surgery, on the 2nd and 7th postoperative days (moment of suture removal),
- beginning and duration of the surgery after anesthetic administration,
- incidence, type and severity of adverse reactions,
- total amount of rescue analgesic medication (paracetamol),
- facial swelling measured on the 2nd and 7th postoperative days (in comparison with the measurements before the surgery).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery with Ketoprofen | Experimental | Drug: KetoprofenFifty healthy volunteers underwent removal one of lower third molar, will be treated to control pain, swelling and trismus with ketoprofen 100 mg |
| Surgery with Ketoprofen and Omeprazole | Experimental | Drug: Ketoprofen and OmeprazoleFifty healthy volunteers underwent removal the other lower third molars, will be treated to control pain, swelling and trismus with ketoprofen 200 mg associated with Omeprazole 20 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Need of lower third molar surgeries in similar positions
Key exclusion criteria (7 listed)
- Presence of systemic diseases;
- Presence of local inflammation and/or infection;
- Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration;
- Cardiovascular, kidney or hepatic diseases;
- Patients who are making use of antidepressants, diuretics or anticoagulants;
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 |
|---|---|---|
| KetoprofenAlso: Lower third molar surgery with KetoprofenClinical efficacy of the Ketoprofen 100 mg was study after lower third molar surgery. | Drug | Surgery with Ketoprofen |
| Ketoprofen and OmeprazoleAlso: Lower third molar surgery with Ketoprofen and OmeprazoleClinical efficacy of the Ketoprofen 200 mg and Omeprazole 20 mg will be study after lower third molar surgery. | Drug | Surgery with Ketoprofen and Omeprazole |
Primary outcome
Subjective evaluation of postsurgical pain
Time frame: Fourth postoperative hour
Subjective evaluation of postsurgical pain, which was annotated by the volunteer, a Visual Analogue Scale (VAS, 0-100 mm) at the fourth postoperative hour.
Quality of anesthesia during surgery based on a category 3point scale
Time frame: During the surgical procedure
Quality of anesthesia during surgery based on a category 3point scale: 1) the patient reported no discomfort; 2) the patient reported discomfort, without the need to supplement the anesthesia; 3) reported some discomfort by the patient, requiring anesthesia complementation. Intraoral bleeding that will be evaluated by the surgeon according to a 3point scale (1: minimal, 2: normal and 3: Maximum), immediately after the following steps: injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing.
Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale
Time frame: During the surgical procedure
Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale (1 minimal bleeding; 2 normal bleeding; 3 excessive bleeding) (SISK, 1986), immediately after the following steps: injection of the first cartridge of articaine, tissue incision, flap reflection, bone removal (when this procedure was necessary), tooth extraction, cleaning of the operated site, and completion of suturing.
Heart rate
Time frame: During the surgical procedure
Median heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters
Oxygen saturation
Time frame: During the surgical procedure
Median oxygen saturation recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.
Systolic blood pressure
Time frame: During the surgical procedure
Median systolic blood pressure to be verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters
Diastolic blood pressure
Time frame: During the surgical procedure
Median diastolic blood pressure to be verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters
5 secondary outcomes
Mouth opening (mm) between the mesial-incisal corners of the upper and lower right central incisors at maximum opening of the jaws
Time frame: Second and Seventh postoperative days
Onset and duration of surgery after administration of anesthetic
Time frame: During the surgery
Incidence, type and severity of adverse reactions
Time frame: Seventh postoperative day
Total amount of rescue medication
Time frame: Seventh postoperative day
Measurement the facial edema distance between the lateral corner of the eye and the gonion, away from the tragus corner of the mouth and away from the tragus to the soft tissue of pogonion.
Time frame: On the second day after surgery and on the seventh day after surgery
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 9 Mar 2017.
- 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.
Luis Fernando Simoneti, DDS principal investigator
University of Sao Paulo
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 Ketoprofen and Ketoprofen and Omeprazole in people with Pain and Other Surgical Procedures, run by Luis Fernando Simoneti at 1 site in Brazil.
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 1 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 9 Mar 2017. 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 Brazil. 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?
Subjective evaluation of postsurgical pain (time frame: Fourth postoperative hour). The study lists 7 primary outcomes in all. 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 9 Mar 2017.