Background: Benzydamine hydrochloride (BNZD) is a nonsteroidal antiinflammatory drug (NSAID) used in an oral rinse formulation as an adjuvant to other NSAIDs in controlling postoperative pain after tonsillectomy, adenoidectomy, or both. Salvia officinalis (SO) is a topically applied herbal preparation frequently used for the same indication. Pain, bleeding, and infection are the most common postoperative complications of tonsillectomy.Objective: The aim of this study was to compare the efficacy and tolerability of BNDZ with those of SO as adjuvant treatments in controlling postoperative pain.Methods: This open-label, single-blind, randomized clinical trial was conducted at the Department of Otorhinolaryngology, Clinical Hospital Center "Dr. Dragi~a Mi~ovi~--Dedinje" (Belgrade, Serbia and Montenegro). Pediatric and adult patients undergoing tonsillectomy, adenoidectomy, or both were enrolled. Patients were randomized to receive BNZD or SO, in addition to ibuprofen 20 mg/kg.d (children) or diclofenac 100 mg/d (adults). The primary end point was the proportion of patients with mild or no pain on postoperative days 1, 2, 4, and 7. Secondary end points were the incidences of infection, hemorrhage, and other adverse events.
Results:
S. Lali~evi6 and L Djordjevi~time point (P < 0.01 at days 1 and 4; P < 0.001 at days 2 and 7). In children, the risk for postoperative infection was similar between BNZD and SO (absolute risk reduction [ARR], 6.9%; 95% CI, 6.4%-?.6%); however, the risk was reduced in adults (ARR, 19.0%; 95% CI, 16.5%-21.9%; P = 0.008).
Conclusions:In this clinical trial of children and adults who underwent tonsillectomy, adenoidectomy, or both, BNZD, as an adjuvant to an NSAID, was more effective than SO in controlling postoperative pain and infection. The pain-reducing effect of BNZD was of quick onset and persisted for 1 week after surgery. The safety profile of BNZD was comparable to that of SO, with the exception of postoperative infection in adults, for which BNZD was more efficacious. In particular, the use of BNZD was not associated with a high risk for early postoperative hemorrhage. (Curt Ther Res Clin Exp.