Sinisa Lalićević1, Ivan Djordjević1. 1. Department of Otorhinolaryngology, Clinical Hospital Center "Dr. Dragiša Mišoviś-Dedinje", Belgrade, Serbia and Montenegro.
Abstract
BACKGROUND:Benzydamine hydrochloride (BNZD) is a nonsteroidal anti-inflammatory 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. Dragiša Mišović-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: A total of 420 patients were enrolled (217 females, 203 males; 278 children, 142 adults; mean [SD] age, 6.2 [2.1] years [children] and 24.1 [9.8] years [adults] [range, 3-45 years]). One hundred thirty-eight children receivedBNZD; 140 received SO (both in addition to ibuprofen 20 mg/kg·d). Seventy-two adults received BNZD; 70 received SO (both in addition to diclofenac 100 mg/d). A significantly lower proportion of children treated with adjuvant BNZD experienced moderate or severe pain than those treated with SO at each 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%-7.6%); 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 underwenttonsillectomy, 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.
RCT Entities:
BACKGROUND:Benzydamine hydrochloride (BNZD) is a nonsteroidal anti-inflammatory 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. Dragiša Mišović-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: A total of 420 patients were enrolled (217 females, 203 males; 278 children, 142 adults; mean [SD] age, 6.2 [2.1] years [children] and 24.1 [9.8] years [adults] [range, 3-45 years]). One hundred thirty-eight children received BNZD; 140 received SO (both in addition to ibuprofen 20 mg/kg·d). Seventy-two adults received BNZD; 70 received SO (both in addition to diclofenac 100 mg/d). A significantly lower proportion of children treated with adjuvant BNZD experienced moderate or severe pain than those treated with SO at each 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%-7.6%); 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.
Entities:
Keywords:
Salvia officinalis; benzydamine hydrochloride; clinical trial; efficacy; safety; tonsillectomy
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