Does Preventive Dexketoprofen Reduce Pain After Orthognathic Surgery

NCT05303688 | Completed

• 1 other identifier: Erü Dentistry
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Preventive analgesia; Pain; Swelling; Orthognathic surgery; Dexketoprofen; 3dMD

Outcome Measures

Primary Outcomes (14)

• Postoperative 1st hours Pain Score on the Visual Analog Scale

  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 1st hours

• Postoperative 3rd hours Pain Score on the Visual Analog Scale

  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 3rd hours.

• Postoperative 6th hours Pain Score on the Visual Analog Scale

  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 6th hours.

• Postoperative 9th hours Pain Score on the Visual Analog Scale

  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 9th hours.

• Postoperative 12th hoursPain Score on the Visual Analog Scale

  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 12th hours.

• Postoperative 24th hours Pain Score on the Visual Analog Scale

  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.

  postoperative 24th hours.

• 3D measure of postoperative swelling

  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

  3D images were taken one (T0) day before surgery.

• 3D measure of postoperative swelling

  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

  3D images were taken 1 (T1) day after surgery.

• 3D measure of postoperative swelling

  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

  3D images were taken3 (T3) day after surgery.

• 3D measure of postoperative swelling

  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

  3D images were taken 7 (T7) day after surgery.

• 3D measure of postoperative swelling

  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

  3D images were taken 14 (T14) day after surgery.

• 3D measure of postoperative swelling

  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

  3D images were taken 21 (T21) day after surgery.

• 3D measure of postoperative swelling

  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

  3D images were taken 30 (T30) day after surgery.

• 3D measure of postoperative swelling

  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

  3D images were taken 90 (T90) day after surgery.

Study Arms (2)

Drug: Dexketoprofen Tremetamol

EXPERIMENTAL

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)

Drug: iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey)

Drug: Steril Salin (control)

PLACEBO COMPARATOR

iv sterile saline were administrated 30 minutes before incision in the placebo group (saline n= 15)

Drug: Steril Salin (control)

Interventions

iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey) DRUG

The primary predictor variable was preventive analgesia group. Patients were randomly divided in two groups. 50 mg iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey) were administrated 30 minutes before incision in the treatment group (dexketoprofen trometamol n= 15

Drug: Dexketoprofen Tremetamol

Steril Salin (control) DRUG

30 minutes before incision in the treatment group (dexketoprofen trometamol n= 15) and iv sterile saline were administrated 30 minutes before incision in the placebo group (saline n= 15).

Drug: Steril Salin (control)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients,
• year-olds,
• ASA I status,
• Class III malocclusion,
• elective double jaw surgery.

You may not qualify if:

• drug allergy,
• liver and kidney failure,
• pregnant or breastfeeding,
• long-term use of pain relievers such as NSAIDs and opioids,
• diabetes

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Yusuf Nuri Kaba

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 31, 2022
• Study Start: March 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: February 1, 2019
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

TU (1)