The Effects of Tramadol Combined With Local Anesthesia on Pain After the Surgical Extraction of Third Molars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-01

Study Completion Date

2014-01-01

Brief Summary

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The purpose of this study was to assess the efficacy of local anesthetic and tramadol combinations in the prevention of pain after the surgical extraction of third molars.

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Detailed Description

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The surgical removal of impacted third molar teeth is a procedure that is frequently encountered in oral and maxillofacial surgery practices. Pain following these operations is one of the most important factors affecting patient satisfaction. Several pain-management strategies are available. An alternative approach to pain control is to maximize drug levels at the tissue injury site by administering drugs locally.

Tramadol is a centrally acting opioid that provides good analgesia. It reduces the transmission of pain impulses by inhibiting serotonin and norepinephrine re-uptake. In addition to the systemic analgesic effects, the local anesthetic effects of tramadol on the peripheral nerves have been presented in multiple clinical and laboratory studies.

The aim of this study is to test the clinical efficacy of local anesthetic and tramadol combinations during and after the surgical extraction of the lower third molars.

Conditions

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Pain After the Surgical Extraction of Third Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The patients were randomly divided into the following two groups using the sealed envelope method.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

The solutions were prepared prior to the procedure by an anesthetic nurse who was not involved in the study. Investigator was blind to the groups.

Study Groups

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Only local anesthetic group

Group Type ACTIVE_COMPARATOR

Only local anesthetic

Intervention Type DRUG

Using articain HCL for inferior alveolar nerve block

Tramadol group

Group Type EXPERIMENTAL

Local anesthetic + tramadol hydrochloride

Intervention Type DRUG

Using tramadol hydrochloride and articain HCL for inferior alveolar nerve block

Interventions

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Local anesthetic + tramadol hydrochloride

Using tramadol hydrochloride and articain HCL for inferior alveolar nerve block

Intervention Type DRUG

Only local anesthetic

Using articain HCL for inferior alveolar nerve block

Intervention Type DRUG

Other Intervention Names

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Articaine

Eligibility Criteria

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Inclusion Criteria

* Score of ASA I-II (American Society of Anesthesiologists Physical Status I or II)
* Patient weights were less than 60 kg

Exclusion Criteria

* Subjects who had taken a sedative, tranquillizer, or analgesic medication within the last 24 h,
* Sensitive to tramadol,
* Patients who needed an extra dose of anesthetic solution during the surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No