Does Preventive Dexketoprofen Reduce Pain After Orthognathic Surgery

Sponsor
TC Erciyes University (Other)
Overall Status
Completed
CT.gov ID
NCT05303688
Collaborator
(none)
30
1
2
11.1
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey)
  • Drug: Steril Salin (control)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Does Preventive Single Dose of Intravenous Dexketoprofen Reduce Pain and Swelling After Orthognathic Surgery? A Prospective, Randomized, Double Blind Clinical Trial
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Drug: Dexketoprofen Tremetamol

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)
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

Placebo Comparator: Drug: Steril Salin (control)

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

Drug: Steril Salin (control)
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).

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 3D measure of postoperative swelling [3D images were taken one (T0) day before 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

  8. 3D measure of postoperative swelling [3D images were taken 1 (T1) 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

  9. 3D measure of postoperative swelling [3D images were taken3 (T3) 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

  10. 3D measure of postoperative swelling [3D images were taken 7 (T7) 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

  11. 3D measure of postoperative swelling [3D images were taken 14 (T14) 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

  12. 3D measure of postoperative swelling [3D images were taken 21 (T21) 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

  13. 3D measure of postoperative swelling [3D images were taken 30 (T30) 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

  14. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yusuf Nuri Kaba Kayseri Melikgazi Turkey 38039

Sponsors and Collaborators

  • TC Erciyes University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yusuf Nuri Kaba, Principal Investigator, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT05303688
Other Study ID Numbers:
  • Erü Dentistry
First Posted:
Mar 31, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yusuf Nuri Kaba, Principal Investigator, TC Erciyes University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022