Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain

NCT ID: NCT05508451

Last Updated: 2022-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-04-01

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.

Detailed Description

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Conditions

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Postoperative Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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paracetamol

Group Type ACTIVE_COMPARATOR

Double jaw surgery

Intervention Type PROCEDURE

A type of orthognathic surgery

tenoxicam

Group Type ACTIVE_COMPARATOR

Double jaw surgery

Intervention Type PROCEDURE

A type of orthognathic surgery

tenoxicam+paracetamol

Group Type ACTIVE_COMPARATOR

Double jaw surgery

Intervention Type PROCEDURE

A type of orthognathic surgery

placebo

Group Type PLACEBO_COMPARATOR

Double jaw surgery

Intervention Type PROCEDURE

A type of orthognathic surgery

Interventions

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Double jaw surgery

A type of orthognathic surgery

Intervention Type PROCEDURE

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. -
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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seher orbay yasli

Medical Doctor, Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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seher Orbay Yaşlı

Role: PRINCIPAL_INVESTIGATOR

Erciyes University Faculty of Dentistry

Locations

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Seher Orbay Yaşlı

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018/303

Identifier Type: -

Identifier Source: org_study_id

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