Research and Publication Ethics: Local ethics committee approval was obtained for the study (Ethical Committee of Ataturk University Hospitals, Erzurum, Turkey (B.30.2.ATA.0.01.00/497).
After the patients signed informed consent forms, 48 patients aged between 18-65 years of age with American Society of Anesthesiologist (ASA) Group I-II, and scheduled for DJS were included in this prospective, randomized and double-blind study.
Patients with known cardiac, pulmonary, renal, hepatic and cardiovascular diseases, history of gastrointestinal bleeding, peptic ulcer or inflammatory intestinal disease, any known NSAID or paracetamol allergy, history of anticoagulant medication use, patients with low platelet counts, those who were pregnant or were planning to become pregnant, and those who could not use the PCA device were excluded from the study.
A total of 48 patients who underwent DJS were included in the study. The patients were divided randomly into two groups at a rate of 1:1 by using a computer program (Microsoft Office 365 Excel with the “RAND” function-Microsoft, Redmond, WA, USA, http://www.microsoft.com) before the intervention. Postoperative pain assessors, patients and practitioners were blinded by the study groups and the drug content. Saline preparations used for control group were prepared with the same volumes of intraoperative infusion solutions as those prepared for the group ibuprofen for double-blindization.
Group 1 (Control Group, n=24) and Group 2 (Group ibuprofen, n=24) were created in this respect. The patients were taken to the surgery room; and iv cannulation was applied. Standard ECG, peripheral oxygen saturation (SpO2), and noninvasive blood pressure monitoring were done. All the measurements were recorded with 5-minute intervals during the surgery.
Group 1 (Control Group, n=24); 100 cc isotonic iv was administered 30 minutes before the surgery.
Group 2 (Ibuprofen Group, n=24); 800mg iv ibuprofen was administered in 100 cc isotonic 30 minutes before the surgery.
General anesthesia was applied to all patients. Before the anesthesia induction, 0.9% NaCl infusion was started, and preoxygenation was done with 100% O₂; and 2-3 mg/kg propofol (Propofol, Fresenius Kabi, Germany), fentanyl (2 μcg /kg), and 0.6 mg/kg rocuronium (Esmeron, Glaxo Smith Kline, England) were administered for the anesthesia induction. All patients underwent nasal intubation. Anesthesia was maintained with 1-2% sevoflurane (Sevorane, AbbVie, England), 50% O2 and 50% air mixture. Crystalloid infusion (8ml/kg/h) was continued during the procedure. The anesthesia depth was monitored with Bispectral Index (BIS), and the BIS value was kept between 40 and 60. At the end of the surgeries, to antagonize the effect of muscle relaxant, 1.5 mg neostigmine (Neostigmine Ampoule 0.5 mg/mL, Adeka, Samsun, Turkey), and 0.5 mg atropine (Atropine Sulfate Ampoule 0.5 mg/mL, Galen, Istanbul) were administered. When the extubation criteria were fully met in the surgery room, nasal extubation was done; and the patient was taken to PACU.
Surgical Technique: The same surgical team performed all surgeries with the same technique.
Local anesthesia was administered to the related right and left areas that would undergo surgery. For each patient, the inferior alveolar, buccal, and lingual nerves were infiltrated with 2% articaine 80 mg in addition to 1:200,000 epinephrine (Ultracain 2%, ampule; Sanofi Aventis, Istanbul, Turkey) before surgery. A vestibular incision was made between the double-sided zygomatic protrusions in the maxilla, and the flap was elevated. Le fort I osteotomy, and then, down fracture were performed. Fixing was done with the plaques and screws that were placed on the right and left. Then, firstly the right side, and then the left side were intervened in the mandibula. Soft tissue incision was performed from the outside of the retrobulbar area on both sides to the 2nd molar tooth. After bone incisions, sagittal split ramus osteotomy was completed. Mandibula and maxilla were connected with splint and wires. Fixation was performed with one mini-plaque and screws on the left and right in the new position. Two drains were placed in the lower jaw, and the surgery was terminated with sutures.
Postoperative Analgesia Management: The same protocol was applied to the groups for postoperative analgesia management. All the patients were administered 1000 mg iv paracetamol (Perfalgan 10 mg/mL, Bristol-Myers Squibb, France) 30 minutes before the surgery ended, and was repeated every 6 hours following the surgery. The PCA device was programmed at 10 μcq concentration with loading dose 50μcq, 15-minute lock time, 25 μcq bolus without basal infusion, and this was continued for 24 hours in the postoperative recovery room. An anesthetist who was blinded to the grouping performed the evaluation of the patients after the DJ S. The postoperative analgesia was evaluated by using VAS (VAS 0=no pain, VAS 10=The most severe pain which can be felt). The VAS scores were recorded at the 1st, 2nd, 4th, 8th, 12th and 24th hours; and 25 mg Meperidine was administered and recorded for the patients with VAS score 4 and above in the recovery room. The side effects related to PCA, such as nausea, vomiting, antiemetic requirement, constipation, itching, urinary retention, and other side effects, such as NSAID related hemorrhage and dyspepsia were questioned during the two-hour postoperative follow up.
The patients with Aldrete Score 9 and above were sent to the ward. The VAS scores after the surgery, and the total opioid consumption were evaluated at the end of the 24th hour.
Statistical Analysis: The IBM SPSS 20.0 (SPSS Inc., Chicago, IL) Program was used for statistical analysis. The distribution of the variables was analyzed in terms of normality with the Kolmogorov-Smirnov and the Histogram Test. Descriptive statistics were given as Mean±Standard Deviation (SD). The categorical variables were analyzed with the Chi-Square Test. Normally distributed data with continuous variables were analyzed with the Independent Sample t-test. Mann-Whitney U-test was used for non-normally distributed data. P<0.05 was considered to be statistically significant.