NCT05508451

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

August 13, 2022

Last Update Submit

August 17, 2022

Conditions

Postoperative Pain, Acute

Keywords

Maxillofacial Orthognathic Surgery; Pain management; Postoperative pain; Tenoxicam

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

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

    during the postoperative 24 hours.

Study Arms (4)

paracetamol

ACTIVE COMPARATOR
Procedure: Double jaw surgery

tenoxicam

ACTIVE COMPARATOR
Procedure: Double jaw surgery

tenoxicam+paracetamol

ACTIVE COMPARATOR
Procedure: Double jaw surgery

placebo

PLACEBO COMPARATOR
Procedure: Double jaw surgery

Interventions

Double jaw surgeryPROCEDURE

A type of orthognathic surgery

paracetamolplacebotenoxicamtenoxicam+paracetamol

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details18-50
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seher Orbay Yaşlı

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • seher Orbay Yaşlı

    Erciyes University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Anesthesiologist

Study Record Dates

First Submitted

August 13, 2022

First Posted

August 19, 2022

Study Start

April 1, 2018

Primary Completion

April 1, 2021

Study Completion

April 1, 2022

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)