A Randomized Controlled Trial Assessing the Effect of Preoperative Ibuprofen Administration on Postoperative Pain Reduction Following Miniscrew Insertion.

Abstract

Objective: To evaluate the impact of preoperative oral ibuprofen premedication as a preemptive analgesia protocol on postoperative pain following the insertion of a single miniscrew insert.

Methods: A randomized, single-blind, placebo-controlled parallel-group trial design was adopted. A total of 68 patients seeking miniscrew insert placement were recruited based on inclusion and exclusion criteria. Patients were randomly assigned in a 1:1 ratio to either the ibuprofen group or the control group, with 34 patients in each group. The ibuprofen group and the control group received 300 mg of ibuprofen sustained-release capsules and a placebo, respectively, 30 min before surgery. Postoperative analgesics were administered as needed. Pain scores at 2, 4, 6, 8, 12, and 24 h postoperatively were recorded using the Numerical Rating Scale (NRS), and the postoperative analgesic consumption was documented.

Results: A total of 68 patients (34 in the control group and 34 in the preemptive analgesia group) completed the trial. No adverse events such as nausea or vomiting occurred in any of the patients. The preemptive analgesia group exhibited significantly lower pain scores at 2, 4, 6, and 8 h postoperatively [2 (0,3), 0 (0,2), 0 (0,0), 0 (0,0.25), respectively] compared to the control group [3 (2,5), 3 (2,4), 2 (0.75,4), 1 (0,3), respectively] (P = 0.0396, P = 0.0067, P = 0.0111, P = 0.0299). The proportions of patients requiring additional analgesics within 2-24 h postoperatively were 17.6% (6/34) in the preemptive analgesia group and 64.7% (22/34) in the control group, with a statistically significant difference between the two groups (P = 0.013).

Conclusion: Preemptive analgesia with ibuprofen can effectively reduce postoperative pain following miniscrew insert placement and represents a safe and effective perioperative pain management strategy.

Trial registration: The UK's Clinical Study Registry; ISRCTN68332234 (Retrospectively registered); 20/12/2024.