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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05614440
Enrollment
60
Registered
2022-11-14
Start date
2012-05-01
Completion date
2014-01-01
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain After the Surgical Extraction of Third Molars

Keywords

tramadol, third molar extraction, analgesia

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.

Interventions

DRUGLocal anesthetic + tramadol hydrochloride

Using tramadol hydrochloride and articain HCL for inferior alveolar nerve block

DRUGOnly local anesthetic

Using articain HCL for inferior alveolar nerve block

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Masking description

The solutions were prepared prior to the procedure by an anesthetic nurse who was not involved in the study. Investigator was blind to the groups.

Intervention model description

The patients were randomly divided into the following two groups using the sealed envelope method.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain48 hoursPostoperative 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

MeasureTime frameDescription
Change in mean blood pressure60 minutesChange in mean blood pressure assessed in baseline (after anesthetic injection), minute 10minute, minute 20, minute 30, minute 40, minute 50, minute 60.
Change in heart rate60 minutesChange in heart rate assessed in baseline (after anesthetic injection), minute 10minute, minute 20, minute 30, minute 40, minute 50, minute 60.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026