Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain

Comparison of the Efficacy of Tenoxicam, Paracetamol (Acetaminophen), and Tenoxicam-Paracetamol Combination on Postoperative Pain in Double-Jaw Surgery Patients

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain, Acute
• Intervention / Treatment: Procedure: Double jaw surgery

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Seher Orbay Yaşlı

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Procedure: Double jaw surgery; A type of orthognathic surgery
Active Comparator: tenoxicam	Procedure: Double jaw surgery; A type of orthognathic surgery
Active Comparator: paracetamol	Procedure: Double jaw surgery; A type of orthognathic surgery
Active Comparator: tenoxicam+paracetamol	Procedure: Double jaw surgery; A type of orthognathic surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary efficacy variable was the number of opioid and rescue drug consumptions during the postoperative 24 hours.	during the postoperative 24 hours.

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: August 13, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Maxillofacial Orthognathic Surgery; Pain management; Postoperative pain; Tenoxicam
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: 2018/303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No