ABSTRACT
OBJECTIVES: The aim of this randomized controlled clinical trial was to evaluate the efficacy and safety of pregabalin administered pre- and postoperatively in patients with pain and swelling due to the surgical removal of impacted lower third molars. MATERIALS AND METHODS: The final study sample comprised 60 volunteers (23 males and 37 females). Group 1 (n = 30) received 75 mg oral pregabalin 1 h before surgery and 1 h after surgery. Group 2 (n = 30) served as a control group and received no pregabalin. Both groups were administered with 650 mg paracetamol every 8 h for 2 days. Postoperative pain intensity and swelling were measured using a visual analog scale (VAS); pain relief experienced was reported using a four-point verbal rating scale (VRS); the rescue medication requirement, adverse effects, and global impression of the medication were also recorded. RESULTS: No significant difference in pain intensity (VAS) was observed between the groups. However, fewer rescue medication tablets were needed by pregabalin-treated patients than by controls (p = 0.021). The frequency and intensity of adverse effects were significantly higher in pregabalin-treated patients (p < 0.001), although no serious adverse events occurred. No significant difference in the degree of swelling was observed in any measurement except that from mandibular angle to lip junction, which showed lesser inflammation in the pregabalin group at 24 h post-surgery (p = 0.011). The global opinion on the medication received was more positive in the pregabalin group (p = 0.042). CONCLUSIONS: The administration of pregabalin reduces the requirement for rescue medication after third molar surgery and results in a more constant pain level, with fewer peaks of pain intensity. CLINICAL RELEVANCE: These findings suggest that pregabalin may be useful to control acute postoperative pain. Adverse effects are known to be reduced at the low pregabalin dose used in our study.
