Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain, Acute

Intervention / Treatment
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* Procedure: Double jaw surgery


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paracetamol<br> | Procedure: Double jaw surgery<br>* A type of orthognathic surgery<br>|
| Active Comparator: tenoxicam<br> | Procedure: Double jaw surgery<br>* A type of orthognathic surgery<br>|
| Active Comparator: tenoxicam+paracetamol<br> | Procedure: Double jaw surgery<br>* A type of orthognathic surgery<br>|
| Placebo Comparator: placebo<br> | Procedure: Double jaw surgery<br>* A type of orthognathic surgery<br>|

What is the study measuring?
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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 | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maxillofacial Orthognathic Surgery; Pain management; Postoperative pain; Tenoxicam