Pain control following impacted mandibular third molar surgery: a comparison of the effectiveness of two different protocols.

Abstract

The use of multimodal analgesia is a common practice in clinical settings, where a combination of drugs with different mechanisms of action is used to enhance the effectiveness of an analgesic and reduce its adverse effects. This study aimed to compare the efficacy of concurrent ibuprofen and paracetamol with alternate administration in the management of postoperative pain after the surgical removal of impacted mandibular third molars. A single-center, double-masked, parallel-group, randomized controlled clinical trial involved 56 patients undergoing scheduled surgical extraction of impacted mandibular third molars. Patients were randomly assigned to either Group A (Control), where they were instructed to take one tablet of ibuprofen 400 mg and two tablets of paracetamol 500 mg together every 8 h for 48 h, or Group B (Study), where they were instructed to take one tablet of ibuprofen 400 mg and two tablets of paracetamol 500 mg alternatively every 4 h for 48 h. The primary outcome measure was the intensity of postoperative pain, which was evaluated using a Visual Analogue Scale (VAS) ranging from 0 to 10. The secondary outcome measure was the timing of the onset of the analgesic effect, the duration of pain relief, the frequency of rescue drug administration, and the time interval between taking the recommended medication and the need for rescue medication. Investigators involved in analyzing the patients' responses were blinded to the pain control regime used by the participants. Pain intensity during the first 48 h after the extractions showed that most participants experienced "some pain," including 50% in Group A and 35.7% in Group B. The percentage of patients reporting "no pain" was higher in group B than in group A, although the difference was not statistically significant (p = 0.495). More than half of the participants (53%) in group A reported needing an extra dose in the 48-hour follow-up period, while 85% in group B reported pain relief (p = 0.002). When correlating the mean pain score to the complexity level, in patients with moderate complexity of extraction, higher pain scores were recorded in group B. The findings of this study show that the combination of Paracetamol and Ibuprofen are well-tolerated and effective option for post operative pain after surgical removal of mandibular third molars. Use of Paracetamol and Ibuprofen alternatively in the first 48 h showed a more effective pain control compared to concurrent use of these medications. However given the small sample size and patients recruited from a single center, multicenter studies with a bigger sample size and stratified complexity groups would enhance the generalizability of the findings.This trial protocol was registered with ClinicalTrials.gov (Registration No: NCT06514222 dated 23/07/2024).