Does Preventive Dexketoprofen Reduce Pain After Orthognathic Surgery

TC Erciyes University

Status: Completed

Conditions: Pain, Postoperative

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05303688

Erü Dentistry

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Drug: Dexketoprofen Tremetamol

Experimental group

Description:

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)

Treatment:

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

Drug: Steril Salin (control)

Placebo Comparator group

Description:

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

Treatment:

Drug: Steril Salin (control)