Clinical trial NCT05614440: The Effects of Tramadol Combined With Local Anesthesia on Pain After the Surgical Extraction of Third Molars
Official title: The Effects of Tramadol Combined With Local Anesthesia on Pain After the Surgical Extraction of Third Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain After the Surgical Extraction of Third Molars
Keywords: tramadol
third molar extraction
analgesia
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The patients were randomly divided into the following two groups using the sealed envelope method.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pain
timeFrame: 48 hours
Secondary outcomes:
measure: Change in mean blood pressure
timeFrame: 60 minutes
measure: Change in heart rate
timeFrame: 60 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Deshpande AA, Hemavathy OR, Krishnan S, Ahmed R. Comparison of effect of intra socket ketamine and tramadol on postoperative pain after mandibular third molar surgery. Natl J Maxillofac Surg. 2022 Jan-Apr;13(1):95-98. doi: 10.4103/njms.NJMS_141_20. Epub 2022 Apr 20.
citation: Vallecillo C, Vallecillo-Rivas M, Galvez R, Vallecillo-Capilla M, Olmedo-Gaya MV. ANALGESIC EFFICACY OF TRAMADOL/DEXKETOPROFEN VS IBUPROFEN AFTER IMPACTED LOWER THIRD MOLAR EXTRACTION: A RANDOMIZED CONTROLLED CLINICAL TRIAL. J Evid Based Dent Pract. 2021 Dec;21(4):101618. doi: 10.1016/j.jebdp.2021.101618. Epub 2021 Jul 28.
citation: Iqbal AM, Shetty P. Effect of Submucosal Injection of Tramadol on Postoperative Pain After Third Molar Surgery. J Oral Maxillofac Surg. 2019 Sep;77(9):1752-1759. doi: 10.1016/j.joms.2019.03.029. Epub 2019 Mar 29.