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

M

Marmara University

Status and phase

Completed
Early Phase 1

Conditions

Pain After the Surgical Extraction of Third Molars

Treatments

Drug: Only local anesthetic
Drug: Local anesthetic + tramadol hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT05614440
153-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

60 participants in 2 patient groups

Only local anesthetic group
Active Comparator group
Treatment:
Drug: Only local anesthetic
Tramadol group
Experimental group
Treatment:
Drug: Local anesthetic + tramadol hydrochloride

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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