Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: A Randomized Controlled Trial.
Journal
Anesthesia and analgesia
ISSN: 1526-7598
Titre abrégé: Anesth Analg
Pays: United States
ID NLM: 1310650
Informations de publication
Date de publication:
01 06 2023
01 06 2023
Historique:
medline:
22
5
2023
pubmed:
3
2
2023
entrez:
2
2
2023
Statut:
ppublish
Résumé
Perioperative respiratory adverse events are common in children. We aimed to evaluate the effect of the transdermal β-2 agonist, tulobuterol, compared with that of placebo on the incidence of perioperative respiratory adverse events in pediatric patients undergoing tonsillectomy. In this triple-blinded (patient, anesthesia provider, and outcome assessor) randomized controlled trial, 188 patients were randomly allocated to receive tulobuterol or a placebo. The tulobuterol groups received a tulobuterol patch (1 mg) masked with a bandage, whereas the placebo only received the bandage. The assigned bandage was applied to the patients 8 to 10 hours before the surgery. The primary outcome was the occurrence of any perioperative respiratory adverse events: oxygen desaturation <95%, airway obstruction, laryngospasm, bronchospasm, severe coughing, or stridor. The outcomes were evaluated using the average relative effect test, which estimates the effect of individual components of a composite outcome and then averages effects across components. A total of 88 and 94 patients who received tulobuterol and placebo, respectively, were analyzed. The incidence of any perioperative respiratory adverse event was lower with tulobuterol (n = 13/88; 14.7%) than that with the placebo (n = 40/94; 42.5%), with an estimated average relative risk (95% confidence interval) across components of 0.35 (0.20-0.60; P < .001). The symptoms of airway obstruction were lower with tulobuterol (n = 8/88; 9.0%) than that with the placebo (n = 32/94; 34.0%), with relative risk (95% CI) of 0.31 (0.17-0.56; P < .001). The occurrence of severe coughing was lower with tulobuterol (n = 1/88; 1.1%) than that with the placebo (n = 8/94; 8.5%), with relative risk (95% CI) of 0.15 (0.03-0.68; P = .014). In preschool children undergoing tonsillectomy, the preoperative application of a tulobuterol patch could decrease the occurrence of perioperative respiratory adverse events. Further studies are needed to elucidate the effect of the tulobuterol patch in a broad spectrum of pediatric anesthesia.
Sections du résumé
BACKGROUND
Perioperative respiratory adverse events are common in children. We aimed to evaluate the effect of the transdermal β-2 agonist, tulobuterol, compared with that of placebo on the incidence of perioperative respiratory adverse events in pediatric patients undergoing tonsillectomy.
METHODS
In this triple-blinded (patient, anesthesia provider, and outcome assessor) randomized controlled trial, 188 patients were randomly allocated to receive tulobuterol or a placebo. The tulobuterol groups received a tulobuterol patch (1 mg) masked with a bandage, whereas the placebo only received the bandage. The assigned bandage was applied to the patients 8 to 10 hours before the surgery. The primary outcome was the occurrence of any perioperative respiratory adverse events: oxygen desaturation <95%, airway obstruction, laryngospasm, bronchospasm, severe coughing, or stridor. The outcomes were evaluated using the average relative effect test, which estimates the effect of individual components of a composite outcome and then averages effects across components.
RESULTS
A total of 88 and 94 patients who received tulobuterol and placebo, respectively, were analyzed. The incidence of any perioperative respiratory adverse event was lower with tulobuterol (n = 13/88; 14.7%) than that with the placebo (n = 40/94; 42.5%), with an estimated average relative risk (95% confidence interval) across components of 0.35 (0.20-0.60; P < .001). The symptoms of airway obstruction were lower with tulobuterol (n = 8/88; 9.0%) than that with the placebo (n = 32/94; 34.0%), with relative risk (95% CI) of 0.31 (0.17-0.56; P < .001). The occurrence of severe coughing was lower with tulobuterol (n = 1/88; 1.1%) than that with the placebo (n = 8/94; 8.5%), with relative risk (95% CI) of 0.15 (0.03-0.68; P = .014).
CONCLUSIONS
In preschool children undergoing tonsillectomy, the preoperative application of a tulobuterol patch could decrease the occurrence of perioperative respiratory adverse events. Further studies are needed to elucidate the effect of the tulobuterol patch in a broad spectrum of pediatric anesthesia.
Identifiants
pubmed: 36727868
doi: 10.1213/ANE.0000000000006355
pii: 00000539-202306000-00010
doi:
Substances chimiques
tulobuterol
591I9SU0F7
Terbutaline
N8ONU3L3PG
Banques de données
ClinicalTrials.gov
['NCT04057469']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1067-1074Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2023 International Anesthesia Research Society.
Déclaration de conflit d'intérêts
The authors declare no conflicts of interest.
Références
de Graaff JC, Sarfo MC, van Wolfswinkel L, van der Werff DB, Schouten AN. Anesthesia-related critical incidents in the perioperative period in children; a proposal for an anesthesia-related reporting system for critical incidents in children. Paediatr Anaesth. 2015;25:621–629.
Ramgolam A, Hall GL, Zhang G, Hegarty M, von Ungern-Sternberg BS. Prediction of peri-operative adverse respiratory events in children: the role of exhaled nitric oxide. Anaesthesia. 2015;70:1160–1164.
von Ungern-Sternberg BS, Ramgolam A, Hall GL, Sly PD, Habre W. Peri-operative adverse respiratory events in children. Anaesthesia. 2015;70:440–444.
Schleelein LE, Vincent AM, Jawad AF, et al. Pediatric perioperative adverse events requiring rapid response: a retrospective case-control study. Paediatr Anaesth. 2016;26:734–741.
Subramanyam R, Yeramaneni S, Hossain MM, Anneken AM, Varughese AM. Perioperative respiratory adverse events in pediatric ambulatory anesthesia: development and validation of a risk prediction tool. Anesth Analg. 2016;122:1578–1585.
von Ungern-Sternberg BS, Sommerfield D, Slevin L, Drake-Brockman TFE, Zhang G, Hall GL. Effect of albuterol premedication vs placebo on the occurrence of respiratory adverse events in children undergoing tonsillectomies: the REACT randomized clinical trial. JAMA Pediatr. 2019;173:527–533.
McGuire SR, Doyle NM. Update on the safety of anesthesia in young children presenting for adenotonsillectomy. World J Otorhinolaryngol Head Neck Surg. 2021;7:179–185.
Sanders K, Osterbauer B, Forman N, et al. Perioperative respiratory adverse events in children undergoing triple endoscopy. Paediatr Anaesth. 2021;31:1290–1297.
Quinn AC, Samaan A, McAteer EM, Moss E, Vucevic M. The reinforced laryngeal mask airway for dento-alveolar surgery. Br J Anaesth. 1996;77:185–188.
Verghese C, Brimacombe JR. Survey of laryngeal mask airway usage in 11,910 patients: safety and efficacy for conventional and nonconventional usage. Anesth Analg. 1996;82:129–133.
Sanders JC, King MA, Mitchell RB, Kelly JP. Perioperative complications of adenotonsillectomy in children with obstructive sleep apnea syndrome. Anesth Analg. 2006;103:1115–1121.
von Ungern-Sternberg BS, Davies K, Hegarty M, Erb TO, Habre W. The effect of deep vs. awake extubation on respiratory complications in high-risk children undergoing adenotonsillectomy: a randomised controlled trial. Eur J Anaesthesiol. 2013;30:529–536.
Ramgolam A, Hall GL, Zhang G, Hegarty M, von Ungern-Sternberg BS. Inhalational versus intravenous induction of anesthesia in children with a high risk of perioperative respiratory adverse events: a randomized controlled trial. Anesthesiology. 2018;128:1065–1074.
Drake-Brockman TF, Ramgolam A, Zhang G, Hall GL, von Ungern-Sternberg BS. The effect of endotracheal tubes versus laryngeal mask airways on perioperative respiratory adverse events in infants: a randomised controlled trial. Lancet. 2017;389:701–708.
Tait AR, Malviya S, Voepel-Lewis T, Munro HM, Seiwert M, Pandit UA. Risk factors for perioperative adverse respiratory events in children with upper respiratory tract infections. Anesthesiology. 2001;95:299–306.
Dadure C, Sabourdin N, Veyckemans F, et al. Management of the child’s airway under anaesthesia: the French guidelines. Anaesth Crit Care Pain Med. 2019;38:681–693.
von Ungern-Sternberg BS, Habre W, Erb TO, Heaney M. Salbutamol premedication in children with a recent respiratory tract infection. Paediatr Anaesth. 2009;19:1064–1069.
Huang HF, Chiu YC, Hunag CJ. Paediatric patients receiving salbutamol inhalation before general anaesthesia are associated with a reduced risk of perioperative adverse respiratory events. Anaesth Crit Care Pain Med. 2021;40:100730.
Tamura G, Ichinose M, Fukuchi Y, Miyamoto T. Transdermal tulobuterol patch, a long-actingβ(2)-agonist. Allergol Int. 2012;61:219–229.
Kim CK, Callaway Z, Choi J, et al.; KAPARD Work Group on Asthma Medication Compliance. Multicenter adherence study of asthma medication for children in Korea. Allergy Asthma Immunol Res. 2019;11:222–230.
Lee DW, Kim ES, Do WS, Lee HB, Kim EJ, Kim CH. The effect of tulobuterol patches on the respiratory system after endotracheal intubation. J Dent Anesth Pain Med. 2017;17:265–270.
Mascha EJ, Imrey PB. Factors affecting power of tests for multiple binary outcomes. Stat Med. 2010;29:2890–2904.
Mascha EJ, Sessler DI. Statistical grand rounds: design and analysis of studies with binary- event composite endpoints: guidelines for anesthesia research. Anesth Analg. 2011;112:1461–1471.
Ng SK, Lee DL, Li AM, Wing YK, Tong MC. Reproducibility of clinical grading of tonsillar size. Arch Otolaryngol Head Neck Surg. 2010;136:159–162.
Ramgolam A, Hall GL, Sommerfield D, et al. Premedication with salbutamol prior to surgery does not decrease the risk of perioperative respiratory adverse events in school-aged children. Br J Anaesth. 2017;119:150–157.
Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med. 2009;28:3083–3107.
Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004;159:702–706.
Fukuchi Y, Nagai A, Seyama K, et al.; Research Group TB. Clinical efficacy and safety of transdermal tulobuterol in the treatment of stable COPD: an open-label comparison with inhaled salmeterol. Treat Respir Med. 2005;4:447–455.
Yamagata T, Hirano T, Sugiura H, et al. Comparison of bronchodilatory properties of transdermal and inhaled long-acting beta 2-agonists. Pulm Pharmacol Ther. 2008;21:160–165.
Ebihara S, Ebihara T, Arai H. Cough and transdermal long-acting beta2 agonist in Japan. Respir Med. 2008;102:1497.
Fu L, Guan J, Zhang Y, et al. Tulobuterol patch alleviates allergic asthmic inflammation by blockade of Syk and NF-κB activation in mice. Oncotarget. 2018;9:12154–12163.
Elwood T, Morris W, Martin LD, et al. Bronchodilator premedication does not decrease respiratory adverse events in pediatric general anesthesia. Can J Anaesth. 2003;50:277–284.
Kobayashi Y, Yasuba H, Kudou M, Kita H. Addition of transdermal or inhaled long-acting Beta2-agonists in adult asthmatic patients treated with inhaled corticosteroids: switchover study from tulobuterol patch to salmeterol dry powder inhaler. J Asthma. 2007;44:77–81.
Inoue H, Niimi A, Matsumoto H, et al. A 12-week, randomized, parallel-group, proof-of-concept study of tulobuterol patch and salmeterol inhaler as add-on therapy in adult-onset mild-to-moderate asthma. Clin Exp Pharmacol Physiol. 2017;44:21–29.