Clinical trial NCT05508451: Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain
Official title: Comparison of the Efficacy of Tenoxicam, Paracetamol (Acetaminophen), and Tenoxicam-Paracetamol Combination on Postoperative Pain in Double-Jaw Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain, Acute
Keywords: Maxillofacial Orthognathic Surgery; Pain management; Postoperative pain; Tenoxicam
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain is generally caused by inflammation and oedema related to tissue trauma. Surgical tissue trauma is caused by many factors such as cotery-related burns, surgical incisions, dissections, and instrumental procedures like cutting, stretching, or compression.

The pain stimulus is triggered by mediators released by the traumatic tissue and transmitted to the spinal cord and then to the upper centres of the brain. Tenoxicam is an analgesic, anti-inflammatory, and antipyretic drug with a long duration of action, included in the oxicam subgroup of NSAIDs. Tenoxicam has been studied and found effective for many rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, gout, extra-articular disorders, bursitis, tendonitis, and osteoarthritis. The primary aim of this study was to compare the effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination analgesic applications on the postoperative VAS score of double-jaw surgery patients. The secondary aim was to investigate the effects of these interventions on the number of both opioid and rescue analgesic drug consumption postoperatively.


Eligibility criteria: Inclusion Criteria:

* Patients between 18-50 aged of both genders who were scheduled for elective bimaxillary surgery
* Classified as American Society of Anesthesiologists (ASA) risk class I or II

Exclusion Criteria:

* having liver or renal dysfunction
* coagulopathy disorder,
* having psychiatric or medical conditions that might impair communication or compliance with the study procedures
* having allergy or contra-indications to the study drugs .pregnancy.
* patients who were planned to undergo additional simultaneous surgical procedures such as genioplasty were not included in the study. -

Primary outcomes:
measure: The effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination on the postoperative 30th minute, first hour and 2th hour VAS (Visual Analog Scale) of double-jaw surgery patients.
timeFrame: at the first hour
measure: The effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination
timeFrame: at the second hour
measure: The effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination
timeFrame: at the 24th hour
Secondary outcomes:
measure: The secondary efficacy variable was the number of opioid and rescue drug consumptions during the postoperative 24 hours.
timeFrame: during the postoperative 24 hours.
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Seher Orbay Yaşlı
Study officials:
affiliation: Erciyes University Faculty of Dentistry
name: seher Orbay Yaşlı
role: PRINCIPAL_INVESTIGATOR
References: