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

Early Phase 1CompletedNCT05614440

Marmara University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain After the Surgical Extraction of Third Molars

Interventions

Local anesthetic + tramadol hydrochlorideDRUG

Using tramadol hydrochloride and articain HCL for inferior alveolar nerve block

Only local anestheticDRUG

Using articain HCL for inferior alveolar nerve block

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in pain

Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable. VAS values were taken from the patient during; post-op 10 minutes, hour 1, hour 2, hour 4, hour 6, hour 12, hour 24, hour 48.

Time frame: 48 hours

Secondary Outcomes

Change in mean blood pressure

Change in mean blood pressure assessed in baseline (after anesthetic injection), minute 10minute, minute 20, minute 30, minute 40, minute 50, minute 60.

Time frame: 60 minutes

Change in heart rate

Change in heart rate assessed in baseline (after anesthetic injection), minute 10minute, minute 20, minute 30, minute 40, minute 50, minute 60.

Time frame: 60 minutes

Data from ClinicalTrials.gov

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