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Completed

NCT Number: NCT05508451

Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain

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.

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Key information

Conditions

Postoperative Pain, Acute Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seher Orbay Yaşlı

Kayseri, 38039, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Double jaw surgery

Procedure

A type of orthognathic surgery

Primary outcomes

  1. 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.

    Time frame: 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

  2. The effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination

    Time frame: at the second hour

    VAS ( Pain intensity was assessed on a 100-mm Visual Analog Scale (VAS), where 0 = no pain and 100 = worst possible pain

  3. The effects of tenoxicam, paracetamol, and tenoxicam-paracetamol combination

    Time frame: 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 outcomes

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

    Time frame: during the postoperative 24 hours.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 19, 2022
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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