Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain

Not Applicable

Completed

• Conditions: Postoperative Pain, Acute
• Interventions: Procedure: Double jaw surgery

• Registration Number: NCT05508451
• Lead Sponsor: TC Erciyes University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2021-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-13
• Study First Submitted QC: 2022-08-17
• Last Update Submitted: 2022-08-17
• Study First Posted: 2022-08-19
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tenoxicam+paracetamol	Double jaw surgery	-
placebo	Double jaw surgery	-
paracetamol	Double jaw surgery	-
tenoxicam	Double jaw surgery	-

Primary Outcome Measures

Name	Time	Method
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.	at the first hour	VAS ( Pain intensity was assessed on a 100-mm Visual Analog Scale (VAS), where 0 = no pain and 100 = worst possible pain
The effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination	at the 24th hour	VAS ( Pain intensity was assessed on a 100-mm Visual Analog Scale (VAS), where 0 = no pain and 100 = worst possible pain

Secondary Outcome Measures

Name	Time	Method
The secondary efficacy variable was the number of opioid and rescue drug consumptions during the postoperative 24 hours.	during the postoperative 24 hours.

Trial Locations

Locations (1)

Seher Orbay Yaşlı; 🇹🇷 Kayseri, Turkey