Clinical trial NCT05303688: Does Preventive Dexketoprofen Reduce Pain After Orthognathic Surgery
Official title: Does Preventive Single Dose of Intravenous Dexketoprofen Reduce Pain and Swelling After Orthognathic Surgery? A Prospective, Randomized, Double Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Preventive analgesia
Pain
Swelling
Orthognathic surgery
Dexketoprofen
3dMD
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative 1st hours Pain Score on the Visual Analog Scale
timeFrame: postoperative 1st hours
measure: Postoperative 3rd hours Pain Score on the Visual Analog Scale
timeFrame: postoperative 3rd hours.
measure: Postoperative 6th hours Pain Score on the Visual Analog Scale
timeFrame: postoperative 6th hours.
measure: Postoperative 9th hours Pain Score on the Visual Analog Scale
timeFrame: postoperative 9th hours.
measure: Postoperative 12th hoursPain Score on the Visual Analog Scale
timeFrame: postoperative 12th hours.
measure: Postoperative 24th hours Pain Score on the Visual Analog Scale
timeFrame: postoperative 24th hours.
measure: 3D measure of postoperative swelling
timeFrame: 3D images were taken one (T0) day before surgery.
measure: 3D measure of postoperative swelling
timeFrame: 3D images were taken 1 (T1) day after surgery.
measure: 3D measure of postoperative swelling
timeFrame: 3D images were taken3 (T3) day after surgery.
measure: 3D measure of postoperative swelling
timeFrame: 3D images were taken 7 (T7) day after surgery.
measure: 3D measure of postoperative swelling
timeFrame: 3D images were taken 14 (T14) day after surgery.
measure: 3D measure of postoperative swelling
timeFrame: 3D images were taken 21 (T21) day after surgery.
measure: 3D measure of postoperative swelling
timeFrame: 3D images were taken 30 (T30) day after surgery.
measure: 3D measure of postoperative swelling
timeFrame: 3D images were taken 90 (T90) day after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Yusuf Nuri Kaba
state: Melikgazi
Study officials:
References: