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

Early Phase 1

Completed

• Conditions: Pain After the Surgical Extraction of Third Molars
• Interventions: Drug: Local anesthetic + tramadol hydrochloride; Drug: Only local anesthetic

• Registration Number: NCT05614440
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study Start: 2012-05-01
• Primary Completion: 2013-11-01
• Study Completion: 2014-01-01
• Study First Submitted: 2022-10-31
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-07
• Last Update Submitted: 2022-11-07
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tramadol group	Local anesthetic + tramadol hydrochloride	-
Only local anesthetic group	Only local anesthetic	-

Primary Outcome Measures

Name	Time	Method
Change in pain	48 hours	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.

Secondary Outcome Measures

Name	Time	Method
Change in heart rate	60 minutes	Change in heart rate assessed in baseline (after anesthetic injection), minute 10minute, minute 20, minute 30, minute 40, minute 50, minute 60.
Change in mean blood pressure	60 minutes	Change in mean blood pressure assessed in baseline (after anesthetic injection), minute 10minute, minute 20, minute 30, minute 40, minute 50, minute 60.