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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Pain After the Surgical Extraction of Third Molars

Intervention / Treatment
-----------------
* Drug: Local anesthetic + tramadol hydrochloride
* Drug: Only local anesthetic


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The patients were randomly divided into the following two groups using the sealed envelope method.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Only local anesthetic group<br> | Drug: Only local anesthetic<br>* Using articain HCL for inferior alveolar nerve block<br>|
| Experimental: Tramadol group<br> | Drug: Local anesthetic + tramadol hydrochloride<br>* Using tramadol hydrochloride and articain HCL for inferior alveolar nerve block<br>* Other names: Articaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tramadol, third molar extraction, analgesia