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Completed

NCT Number: NCT05614440

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

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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Key information

Conditions

Pain After the Surgical Extraction of Third Molars Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local anesthetic + tramadol hydrochloride

Drug

Using tramadol hydrochloride and articain HCL for inferior alveolar nerve block

Other names: Articaine

Only local anesthetic

Drug

Using articain HCL for inferior alveolar nerve block

Primary outcomes

  1. Change in pain

    Time frame: 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 outcomes

  1. Change in mean blood pressure

    Time frame: 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.

  2. Change in heart rate

    Time frame: 60 minutes

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

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 14, 2022
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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