Transdermal scopolamine for the prevention of postoperative nausea and vomiting: A systematic review and meta-analysis

Christian C. Apfel, Kun Zhang, Elizabeth George, Serena Shi, Leena Jalota, Cyrill Hornuss, Katherine E. Fero, Felix Heidrich, Joseph V. Pergolizzi, Ozlem S. Cakmakkaya, Peter Kranke

Research output: Contribution to journalArticle

Abstract

Background: Transdermal scopolamine (TDS) is a potential long-acting prophylactic antiemetic initially developed to prevent motion sickness. TDS is a centrally acting anticholinergic agent that was approved in 2001 by the US Food and Drug Administration for the prevention of postoperative nausea and vomiting (PONV). Although TDS has been reported to be clinically efficacious in the prevention of PONV, several adverse events (AEs), such as sedation, dry mouth, blurred vision, central cholinergic syndrome, and confusion (particularly in elderly patients with mild cognitive impairment), are potential concerns.Objective: The aim of this study was to explore the efficacy and tolerability of TDS in the prevention of PONV in adults.Methods: A systematic search of PubMed, EMBASE, and the Cochrane Library for randomized controlled trials in adults that compared the effects of TDS and placebo on postoperative nausea, vomiting, and PONV was conducted in March 2009, and an update was conducted in July 2010. Without any language restrictions, a search with the following terms was performed: postoperative, postoperative, postanesthe*, postanaesthe*, post-anesthe*, post-anaesthe*, anesthesia, anaesthesia, surgery, surgeries, surgical, nausea, vomiting, emesis, retching, scopolamine, and hyoscine. Identified studies were then hand-searched for further relevant literature.Results: Data from 25 randomized controlled trials were analyzed (N = 3298). In the postanesthesia care unit, TDS was associated with a significantly reduced risk for postoperative nausea compared with placebo (relative risk [RR] = 0.77; 95% CI, 0.61-0.98; P = 0.03). TDS was also associated with a significantly reduced risk for postoperative nausea (RR = 0.59; 95% CI, 0.48-0.73; P <0.001), postoperative vomiting (RR = 0.68; 95% CI, 0.61-0.76; P <0.001), and PONV (RR = 0.73; 95% CI, 0.60-0.88; P = 0.001) during the first 24 hours after the start of anesthesia. TDS appeared to be effective compared with placebo in the prevention of postoperative nausea when treatment was initiated the night before (early application) (RR = 0.56; 95% CI, 0.41-0.75; P <0.001) or on the day of surgery (late application) (RR = 0.61; 95% CI, 0.47-0.79; P <0.001). TDS was associated with a higher prevalence of visual disturbances at 24 to 48 hours compared with placebo (RR = 3.35; 95% CI, 1.78-6.32). Analyses of confusion and other AEs did not show a significant association with TDS.Conclusions: In this systematic review and metaanalysis, TDS was associated with significant reductions in PONV with both early and late patch application during the first 24 hours after the start of anesthesia. TDS was associated with a higher prevalence of visual Accepted for publication September 21, 2010. disturbances at 24 to 48 hours after surgery, but no other AEs, compared with placebo.

Original languageEnglish (US)
Pages (from-to)1987-2002
Number of pages16
JournalClinical Therapeutics
Volume32
Issue number12
DOIs
StatePublished - Nov 2010

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Postoperative Nausea and Vomiting
Scopolamine Hydrobromide
Meta-Analysis
Placebos
Anesthesia
Vomiting
Randomized Controlled Trials
Motion Sickness
Confusion
Antiemetics
Cholinergic Antagonists
United States Food and Drug Administration
Ambulatory Surgical Procedures
PubMed
Nausea
Cholinergic Agents
Libraries

Keywords

  • Antiemetic
  • Meta-analysis
  • PONV
  • Postoperative nausea
  • Postoperative vomiting
  • Prophylaxis
  • Systematic review
  • Transdermal scopolamine patch

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Transdermal scopolamine for the prevention of postoperative nausea and vomiting : A systematic review and meta-analysis. / Apfel, Christian C.; Zhang, Kun; George, Elizabeth; Shi, Serena; Jalota, Leena; Hornuss, Cyrill; Fero, Katherine E.; Heidrich, Felix; Pergolizzi, Joseph V.; Cakmakkaya, Ozlem S.; Kranke, Peter.

In: Clinical Therapeutics, Vol. 32, No. 12, 11.2010, p. 1987-2002.

Research output: Contribution to journalArticle

Apfel, CC, Zhang, K, George, E, Shi, S, Jalota, L, Hornuss, C, Fero, KE, Heidrich, F, Pergolizzi, JV, Cakmakkaya, OS & Kranke, P 2010, 'Transdermal scopolamine for the prevention of postoperative nausea and vomiting: A systematic review and meta-analysis', Clinical Therapeutics, vol. 32, no. 12, pp. 1987-2002. https://doi.org/10.1016/j.clinthera.2010.11.014
Apfel, Christian C. ; Zhang, Kun ; George, Elizabeth ; Shi, Serena ; Jalota, Leena ; Hornuss, Cyrill ; Fero, Katherine E. ; Heidrich, Felix ; Pergolizzi, Joseph V. ; Cakmakkaya, Ozlem S. ; Kranke, Peter. / Transdermal scopolamine for the prevention of postoperative nausea and vomiting : A systematic review and meta-analysis. In: Clinical Therapeutics. 2010 ; Vol. 32, No. 12. pp. 1987-2002.
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TY - JOUR

T1 - Transdermal scopolamine for the prevention of postoperative nausea and vomiting

T2 - A systematic review and meta-analysis

AU - Apfel, Christian C.

AU - Zhang, Kun

AU - George, Elizabeth

AU - Shi, Serena

AU - Jalota, Leena

AU - Hornuss, Cyrill

AU - Fero, Katherine E.

AU - Heidrich, Felix

AU - Pergolizzi, Joseph V.

AU - Cakmakkaya, Ozlem S.

AU - Kranke, Peter

PY - 2010/11

Y1 - 2010/11

N2 - Background: Transdermal scopolamine (TDS) is a potential long-acting prophylactic antiemetic initially developed to prevent motion sickness. TDS is a centrally acting anticholinergic agent that was approved in 2001 by the US Food and Drug Administration for the prevention of postoperative nausea and vomiting (PONV). Although TDS has been reported to be clinically efficacious in the prevention of PONV, several adverse events (AEs), such as sedation, dry mouth, blurred vision, central cholinergic syndrome, and confusion (particularly in elderly patients with mild cognitive impairment), are potential concerns.Objective: The aim of this study was to explore the efficacy and tolerability of TDS in the prevention of PONV in adults.Methods: A systematic search of PubMed, EMBASE, and the Cochrane Library for randomized controlled trials in adults that compared the effects of TDS and placebo on postoperative nausea, vomiting, and PONV was conducted in March 2009, and an update was conducted in July 2010. Without any language restrictions, a search with the following terms was performed: postoperative, postoperative, postanesthe*, postanaesthe*, post-anesthe*, post-anaesthe*, anesthesia, anaesthesia, surgery, surgeries, surgical, nausea, vomiting, emesis, retching, scopolamine, and hyoscine. Identified studies were then hand-searched for further relevant literature.Results: Data from 25 randomized controlled trials were analyzed (N = 3298). In the postanesthesia care unit, TDS was associated with a significantly reduced risk for postoperative nausea compared with placebo (relative risk [RR] = 0.77; 95% CI, 0.61-0.98; P = 0.03). TDS was also associated with a significantly reduced risk for postoperative nausea (RR = 0.59; 95% CI, 0.48-0.73; P <0.001), postoperative vomiting (RR = 0.68; 95% CI, 0.61-0.76; P <0.001), and PONV (RR = 0.73; 95% CI, 0.60-0.88; P = 0.001) during the first 24 hours after the start of anesthesia. TDS appeared to be effective compared with placebo in the prevention of postoperative nausea when treatment was initiated the night before (early application) (RR = 0.56; 95% CI, 0.41-0.75; P <0.001) or on the day of surgery (late application) (RR = 0.61; 95% CI, 0.47-0.79; P <0.001). TDS was associated with a higher prevalence of visual disturbances at 24 to 48 hours compared with placebo (RR = 3.35; 95% CI, 1.78-6.32). Analyses of confusion and other AEs did not show a significant association with TDS.Conclusions: In this systematic review and metaanalysis, TDS was associated with significant reductions in PONV with both early and late patch application during the first 24 hours after the start of anesthesia. TDS was associated with a higher prevalence of visual Accepted for publication September 21, 2010. disturbances at 24 to 48 hours after surgery, but no other AEs, compared with placebo.

AB - Background: Transdermal scopolamine (TDS) is a potential long-acting prophylactic antiemetic initially developed to prevent motion sickness. TDS is a centrally acting anticholinergic agent that was approved in 2001 by the US Food and Drug Administration for the prevention of postoperative nausea and vomiting (PONV). Although TDS has been reported to be clinically efficacious in the prevention of PONV, several adverse events (AEs), such as sedation, dry mouth, blurred vision, central cholinergic syndrome, and confusion (particularly in elderly patients with mild cognitive impairment), are potential concerns.Objective: The aim of this study was to explore the efficacy and tolerability of TDS in the prevention of PONV in adults.Methods: A systematic search of PubMed, EMBASE, and the Cochrane Library for randomized controlled trials in adults that compared the effects of TDS and placebo on postoperative nausea, vomiting, and PONV was conducted in March 2009, and an update was conducted in July 2010. Without any language restrictions, a search with the following terms was performed: postoperative, postoperative, postanesthe*, postanaesthe*, post-anesthe*, post-anaesthe*, anesthesia, anaesthesia, surgery, surgeries, surgical, nausea, vomiting, emesis, retching, scopolamine, and hyoscine. Identified studies were then hand-searched for further relevant literature.Results: Data from 25 randomized controlled trials were analyzed (N = 3298). In the postanesthesia care unit, TDS was associated with a significantly reduced risk for postoperative nausea compared with placebo (relative risk [RR] = 0.77; 95% CI, 0.61-0.98; P = 0.03). TDS was also associated with a significantly reduced risk for postoperative nausea (RR = 0.59; 95% CI, 0.48-0.73; P <0.001), postoperative vomiting (RR = 0.68; 95% CI, 0.61-0.76; P <0.001), and PONV (RR = 0.73; 95% CI, 0.60-0.88; P = 0.001) during the first 24 hours after the start of anesthesia. TDS appeared to be effective compared with placebo in the prevention of postoperative nausea when treatment was initiated the night before (early application) (RR = 0.56; 95% CI, 0.41-0.75; P <0.001) or on the day of surgery (late application) (RR = 0.61; 95% CI, 0.47-0.79; P <0.001). TDS was associated with a higher prevalence of visual disturbances at 24 to 48 hours compared with placebo (RR = 3.35; 95% CI, 1.78-6.32). Analyses of confusion and other AEs did not show a significant association with TDS.Conclusions: In this systematic review and metaanalysis, TDS was associated with significant reductions in PONV with both early and late patch application during the first 24 hours after the start of anesthesia. TDS was associated with a higher prevalence of visual Accepted for publication September 21, 2010. disturbances at 24 to 48 hours after surgery, but no other AEs, compared with placebo.

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KW - Meta-analysis

KW - PONV

KW - Postoperative nausea

KW - Postoperative vomiting

KW - Prophylaxis

KW - Systematic review

KW - Transdermal scopolamine patch

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