Does Preventive Dexketoprofen Reduce Pain After Orthognathic Surgery

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Steril Salin (control); Drug: iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey)

• Registration Number: NCT05303688
• Lead Sponsor: TC Erciyes University

Brief Summary

Background The purpose of this study was to evaluate the effect of a single-dose intravenous dexketoprofen administration for preventive analgesia on postoperative pain and reducing swelling in double jaw surgery.

Material and Methods The authors designed a prospective, randomized, and double-blind cohort study. Patients who have Class III malocclusion were randomly divided in two groups. 50 mg intravenous dexketoprofen trometamol were administrated 30 minutes before incision in treatment group, while intravenous sterile saline was administrated 30 minutes before incision in placebo group. The primary predictor variable was treatment group. Primary outcomes were pain, swelling and 24-hour opioid intake. Patient- controlled analgesia with tramadol was given for management of postoperative pain. Other variables were demographic and operation related parameters. Visual analogue scale was used to evaluate postoperative pain. 3dMD Face System (3dMD, USA) was used to measure postoperative swelling. Data were analysed using two independent samples t test and Mann Whitney U test.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-10-01
• Study Completion: 2019-02-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Inclusion criteria for this study were as follows;
• patients,
• 18-45-year-olds,
• ASA I status,
• Class III malocclusion,
• elective double jaw surgery.

Exclusion Criteria

• Exclusion criteria were ASA II and above,
• drug allergy,
• liver and kidney failure,
• pregnant or breastfeeding,
• long-term use of pain relievers such as NSAIDs and opioids,
• diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: Steril Salin (control)	Steril Salin (control)	iv sterile saline were administrated 30 minutes before incision in the placebo group (saline n= 15)
Drug: Dexketoprofen Tremetamol	iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey)	50 mg iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, Istanbul, Turkey) were administrated 30 minutes before incision in the treatment group (deksketoprofen trometamol n= 15)

Primary Outcome Measures

Name	Time	Method
Postoperative 6th hours Pain Score on the Visual Analog Scale	postoperative 6th hours.	The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 6th hours."0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
Postoperative 1st hours Pain Score on the Visual Analog Scale	postoperative 1st hours	The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 1st hours. "0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
Postoperative 3rd hours Pain Score on the Visual Analog Scale	postoperative 3rd hours.	The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 3rd hours. "0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
Postoperative 9th hours Pain Score on the Visual Analog Scale	postoperative 9th hours.	The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 9th hours."0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
Postoperative 12th hoursPain Score on the Visual Analog Scale	postoperative 12th hours.	The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 12th hours. "0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
Postoperative 24th hours Pain Score on the Visual Analog Scale	postoperative 24th hours.	The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 24th hours. "0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
3D measure of postoperative swelling	3D images were taken 90 (T90) day after surgery.	3dMD Face System (3dMD, ATLANTA, GA, USA) was used for 3D imaging of postoperative swelling. The same clinician took the 3D images from patients in natural head position, maximum intercuspation and eyes open. The 3dMD Vultus Software (3dMD, Atlanta, GA) was used to analyse the images. The 3-month postoperative 3D image (t90) was selected as the reference image to compare with other images. After cutting and customizing the images by anatomical structures, scans t0-t30 were matched to the reference scan t90. The forehead, nasion, tragus, medial and lateral canthus were used for surface matching. After surface matching, the volume difference between the masks was calculated

Trial Locations

Locations (1)

Yusuf Nuri Kaba; 🇹🇷 Kayseri, Melikgazi, Turkey