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PainPhase 4NCT02494856

Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal

A Phase 4 study testing Surgery with Naproxen and Surgery with Naproxen and Esomeprazole in people with Pain and Other Surgical Procedures, run by Giovana Maria Weckwerth at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present clinical trial randomized compared the clinical efficacy of the naproxen associated or not with esomeprazol, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Surgery with Naproxen and Surgery with Naproxen and Esomeprazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBrazil
Study dates
Oct 2014to Mar 2016
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;
Show all 9Show fewer
  • Regular use of any nonsteroidal antiinflammatory drug,
  • pregnancy or
  • breast feeding.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • University of São Paulo

    Bauru, São Paulo, 17012-901

Other trials in Brazil

About this study

Official title: Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in the Control of Pain, Swelling and Trismus in Lower Third Molar Removal

The present clinical trial randomized compared the clinical efficacy of the naproxen associated or not with esomeprazol, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 4% (1:200,000 adrenaline) in a doubleblind, randomized and crossed manner.

Read the detailed description

The control of pain, swelling and trismus in patients undergoing oral and maxillofacial surgery is frequently performed through the administration of non-steroidal antiinflammatory drugs (NSAIDS). 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 present study aims to evaluate in a double blind, randomized and cross over manner the clinical efficacy of naproxen (500 mg) and naproxen in association with esomeprazol (500 mg and 20 mg), both administered by oral route every 12 h during 4 days, in 50 patients aged 18 years or older that require removal of both lower third molars symmetrically positioned. The following parameters will be analyzed: 1) subjective postoperative pain evaluation, with the aid of a visual analogue scale, 2) mouth opening before the surgery, on the 2nd and 7th postoperative days (moment of suture removal), 3) beginning and duration of the surgery after anesthetic administration, 4) incidence, type and severity of adverse reactions, 5) total amount of rescue analgesic medication (paracetamol), 6) facial swelling measured on the 2nd and 7th postoperative days (in comparison with the measurements before the surgery). The comparative analyses of the data along with the application of the adequate statistical tests will provide the basis for an evaluation of the clinical efficacy of both NSAIDS.

Being tested
Surgery with Naproxen, Surgery with Naproxen and Esomeprazole
Keywords
Naproxen, Lower third molar, Oral Surgery, Esomeprazole
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgery with NaproxenDrug

    Also called Lower third molar surgery with Naproxen

    After lower third molars surgeries, clinical efficacy of the Naproxen 500mg was study.

  • Surgery with Naproxen and EsomeprazoleDrug

    Also called Lower third molar surgery with Naproxen and Esomeprazole

    After lower third molars surgeries, clinical efficacy of the Naproxen 500mg and Esomeprazole 20mg was study.

Study groups in NCT02494856
Study groupRoleWhat they receive
Surgery with NaproxenExperimentalFifty healthy volunteers underwent removal of symmetrically positioned lower third molars, will be treated to control pain, swelling and trismus with naproxen 500mg.
Receives: Drug: Surgery with Naproxen
Surgery with Naproxen and EsomeprazoleExperimentalFifty healthy volunteers underwent removal of symmetrically positioned lower third molars, will be treated to control pain, swelling and trismus with naproxen 500mg and esomeprazole 20mg.
Receives: Drug: Surgery with Naproxen and Esomeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of postsurgical pain

    Subjective evaluation of postsurgical pain, which was annotated by the volunteer, a Visual Analogue Scale (VAS, 0-100 mm) and total amount (mg) of rescue medication consumption in the postoperative period. The subjective pain evaluations will be performed by patients at the following times after administration of the drugs [0, 15, 30 and 45 min, 1; 1.5; 2; 3; 4; 5; 6; 7; 8; 10; 12; 16; 24 hr, 48, 72 and 96 h].

    Measured: Seventh postoperative day

  2. Quality of anesthesia

    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

  3. Intraoperative bleeding

    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

  4. Blood pressure

    Systolic blood pressure, diastolic, and mean 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

  5. Heart rate

    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

  6. Oxygen saturation

    Oxygen saturation to be verified and recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.

    Measured: During the surgical procedure

Secondary outcomes (5)

  1. Postoperative mouth opening

    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

  2. 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

  3. 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

  4. 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

  5. Measurement the facial edema

    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.

  1. First posted10 Jul 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2015
  4. Study completionMar 2016

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02494856
Sponsor's protocol ID
CAAE: 30317314.4.0000.5417
Status last verified
Nov 2016
First submitted
7 Jul 2015
Last updated
4 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Surgery with Naproxen and Surgery with Naproxen and Esomeprazole in people with Pain and Other Surgical Procedures, run by Giovana Maria Weckwerth 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 9 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 Nov 2016. 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?

Evaluation of postsurgical pain (time frame: Seventh postoperative day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02494856.

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 Nov 2016.

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