NCT05303688

Does Preventive Dexketoprofen Reduce Pain After Orthognathic Surgery

Does Preventive Single Dose of Intravenous Dexketoprofen Reduce Pain and Swelling After Orthognathic Surgery? A Prospective, Randomized, Double Blind Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: TC Erciyes University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
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).

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-10-01
• Completion: 2019-02-01
• First posted: 2022-03-31
• Last updated: 2022-03-31

Locations

1 site across 1 country: Turkey (Türkiye)