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Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain

Primary Purpose

Postoperative Pain, Acute

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Double jaw surgery

About this trial

This is an interventional treatment trial for Postoperative Pain, Acute focused on measuring Maxillofacial Orthognathic Surgery; Pain management; Postoperative pain; Tenoxicam

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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. -

Sites / Locations

Seher Orbay Yaşlı

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

paracetamol

tenoxicam

tenoxicam+paracetamol

placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05508451

First Posted

August 13, 2022

Last Updated

August 17, 2022

Sponsor

TC Erciyes University

1. Study Identification

Unique Protocol Identification Number

NCT05508451

Brief Title

Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

April 1, 2018 (Actual)

Primary Completion Date

April 1, 2021 (Actual)

Study Completion Date

April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Acute

Keywords

Maxillofacial Orthognathic Surgery; Pain management; Postoperative pain; Tenoxicam

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

paracetamol

Arm Type

Active Comparator

Arm Title

tenoxicam

Arm Type

Active Comparator

Arm Title

tenoxicam+paracetamol

Arm Type

Active Comparator

Arm Title

placebo

Arm Type

Placebo Comparator

Intervention Type

Procedure

Intervention Name(s)

Double jaw surgery

Intervention Description

A type of orthognathic surgery

Primary Outcome Measure Information:

Title

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.

Description

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

Time Frame

at the first hour

Title

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

Description

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

Time Frame

at the second hour

Title

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

Description

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

Time Frame

at the 24th hour

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

18-50

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

seher Orbay Yaşlı

Organizational Affiliation

Erciyes University Faculty of Dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seher Orbay Yaşlı

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of the Effects of Tenoxicam and Paracetamol on Postoperative Pain

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