Comparison of benzydamine hydrochloride and Salvia officinalis as an adjuvant local treatment to systemic nonsteroidal anti-inflammatory drug in controlling pain after tonsillectomy, adenoidectomy, or both: an open-label, single-blind, randomized clinical trial

Abstract

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.

Dexmedetomidine reduces emergence agitation after tonsillectomy in children by sevoflurane anesthesia: A case-control study

“…In this study, the high ratio of emergence agitation accompanied with high visual analog scale (VAS), the ratio of emergence agitation decreased when levels of postoperative pain was restrained, which verified that levels of postoperative pain in young children are associated with more emergence agitation. This finding supports the notion that inadequate postoperative pain control and sedation may have contributed to the large differences in emergence agitation noted in other studies [3,4,30,31]. The incident of EA was also decrease with the deepen of sedation, which means the incident of EA is correlated to the degree of sedation, this is in accordance with other researches' results [32][33][34].…”

“…Several studies indicate that pain treatment after tonsillectomy has been inadequate [1][2][3][4]30,31]. Up to recent years opioids are widely used analgesics for peri-and postoperative pain in children.…”

Meta-Analysis of Dexmedetomidine on Emergence Agitation and Recovery Profiles in Children after Sevoflurane Anesthesia: Different Administration and Different Dosage

“…Analgesia, one of main pharmacological properties of dexmedetomidine, is deemed to play an important role in preventing EA after inhalation anesthesia. Some studies found that although the pain alone could not cause EA [ 58 , 59 ], inadequate postoperative pain control may be closely associated with varying differences in the incidence of EA[ 60 , 61 ], therefore it is one of major causes of the increased frequency and severity of EA[ 6 , 62 ]. For children, it is too difficult to describe pain objectively, therefore various pain assessment tools such as the visual analogue scale (VAS) [ 63 ] and the objective pain scale (OPS) [ 64 ] were to compare the number of patients who needed post-anesthesia pain control.…”

Pharmacological properties of Salvia officinalis and its components

“…72 However, this effect of S. officinalis is not more powerful than the benzydamine hydrochloride in controlling postoperative pain after tonsillectomy or adenoidectomy. 73 …”