Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy

C. M. Bolton, P. S. Myles, J. B. Carlin, T. Nolan

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background. Postoperative vomiting (POV) is a major cause of morbidity after tonsillectomy in children. It has been well established that anti-serotinergic agents are effective for the prophylactic control of POV in this patient group. It has been suggested that at moderate doses (0.5 mg kg -1), metoclopramide is also an effective agent. No study has been performed comparing the efficacy of an anti-serotinergic agent and moderate-dose metoclopramide. Methods. A total of 557 children undergoing tonsillectomy with or without adenoidectomy were randomly allocated to receive either ondansetron 0.1 mg kg-1 or metoclopramide 0.5 mg kg-1. All received a standardized muscle-relaxant anaesthetic and dexamethasone 0.1 mg kg -1. The primary outcome was any vomit in the immediate postoperative period. Comparisons were made of the proportion in each group reaching the primary outcome and the time until their first vomit. The study was designed to detect equivalence. Results. The incidence of vomiting in the group receiving ondansetron (25.3%) was 12% lower (95% CI 4.4-19.7) than those in metoclopramide (37.3%). The time until first vomit was significantly longer in the group receiving ondansetron (hazard ratio 0.61, 95% CI 0.45-0.82). Conclusions. Although the incidence of vomiting was similar, when these results are compared with a pre-specified zone of equivalence of 0-15%, it cannot be concluded that the effect of metoclopramide is equivalent to ondansetron. Survival analysis indicated that those in the metoclopramide group vomited substantially earlier. It is concluded, therefore, that ondansetron 0.1 mg kg-1 is a superior drug to metoclopramide 0.5 mg kg-1 for the prophylactic control of POV in children undergoing tonsillectomy.

Original languageEnglish
Pages (from-to)699-703
Number of pages5
JournalBritish Journal of Anaesthesia
Volume99
Issue number5
DOIs
Publication statusPublished - Nov 2007

Keywords

  • Anaesthesia, paediatric
  • Clinical trials
  • Surgery, otolaryngological
  • Vomiting, incidence

Cite this

@article{a70775d8a20c4a5cae28bbd4540dedd3,
title = "Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy",
abstract = "Background. Postoperative vomiting (POV) is a major cause of morbidity after tonsillectomy in children. It has been well established that anti-serotinergic agents are effective for the prophylactic control of POV in this patient group. It has been suggested that at moderate doses (0.5 mg kg -1), metoclopramide is also an effective agent. No study has been performed comparing the efficacy of an anti-serotinergic agent and moderate-dose metoclopramide. Methods. A total of 557 children undergoing tonsillectomy with or without adenoidectomy were randomly allocated to receive either ondansetron 0.1 mg kg-1 or metoclopramide 0.5 mg kg-1. All received a standardized muscle-relaxant anaesthetic and dexamethasone 0.1 mg kg -1. The primary outcome was any vomit in the immediate postoperative period. Comparisons were made of the proportion in each group reaching the primary outcome and the time until their first vomit. The study was designed to detect equivalence. Results. The incidence of vomiting in the group receiving ondansetron (25.3{\%}) was 12{\%} lower (95{\%} CI 4.4-19.7) than those in metoclopramide (37.3{\%}). The time until first vomit was significantly longer in the group receiving ondansetron (hazard ratio 0.61, 95{\%} CI 0.45-0.82). Conclusions. Although the incidence of vomiting was similar, when these results are compared with a pre-specified zone of equivalence of 0-15{\%}, it cannot be concluded that the effect of metoclopramide is equivalent to ondansetron. Survival analysis indicated that those in the metoclopramide group vomited substantially earlier. It is concluded, therefore, that ondansetron 0.1 mg kg-1 is a superior drug to metoclopramide 0.5 mg kg-1 for the prophylactic control of POV in children undergoing tonsillectomy.",
keywords = "Anaesthesia, paediatric, Clinical trials, Surgery, otolaryngological, Vomiting, incidence",
author = "Bolton, {C. M.} and Myles, {P. S.} and Carlin, {J. B.} and T. Nolan",
year = "2007",
month = "11",
doi = "10.1093/bja/aem236",
language = "English",
volume = "99",
pages = "699--703",
journal = "British Journal of Anaesthesia",
issn = "0007-0912",
publisher = "Oxford University Press",
number = "5",

}

Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy. / Bolton, C. M.; Myles, P. S.; Carlin, J. B.; Nolan, T.

In: British Journal of Anaesthesia, Vol. 99, No. 5, 11.2007, p. 699-703.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy

AU - Bolton, C. M.

AU - Myles, P. S.

AU - Carlin, J. B.

AU - Nolan, T.

PY - 2007/11

Y1 - 2007/11

N2 - Background. Postoperative vomiting (POV) is a major cause of morbidity after tonsillectomy in children. It has been well established that anti-serotinergic agents are effective for the prophylactic control of POV in this patient group. It has been suggested that at moderate doses (0.5 mg kg -1), metoclopramide is also an effective agent. No study has been performed comparing the efficacy of an anti-serotinergic agent and moderate-dose metoclopramide. Methods. A total of 557 children undergoing tonsillectomy with or without adenoidectomy were randomly allocated to receive either ondansetron 0.1 mg kg-1 or metoclopramide 0.5 mg kg-1. All received a standardized muscle-relaxant anaesthetic and dexamethasone 0.1 mg kg -1. The primary outcome was any vomit in the immediate postoperative period. Comparisons were made of the proportion in each group reaching the primary outcome and the time until their first vomit. The study was designed to detect equivalence. Results. The incidence of vomiting in the group receiving ondansetron (25.3%) was 12% lower (95% CI 4.4-19.7) than those in metoclopramide (37.3%). The time until first vomit was significantly longer in the group receiving ondansetron (hazard ratio 0.61, 95% CI 0.45-0.82). Conclusions. Although the incidence of vomiting was similar, when these results are compared with a pre-specified zone of equivalence of 0-15%, it cannot be concluded that the effect of metoclopramide is equivalent to ondansetron. Survival analysis indicated that those in the metoclopramide group vomited substantially earlier. It is concluded, therefore, that ondansetron 0.1 mg kg-1 is a superior drug to metoclopramide 0.5 mg kg-1 for the prophylactic control of POV in children undergoing tonsillectomy.

AB - Background. Postoperative vomiting (POV) is a major cause of morbidity after tonsillectomy in children. It has been well established that anti-serotinergic agents are effective for the prophylactic control of POV in this patient group. It has been suggested that at moderate doses (0.5 mg kg -1), metoclopramide is also an effective agent. No study has been performed comparing the efficacy of an anti-serotinergic agent and moderate-dose metoclopramide. Methods. A total of 557 children undergoing tonsillectomy with or without adenoidectomy were randomly allocated to receive either ondansetron 0.1 mg kg-1 or metoclopramide 0.5 mg kg-1. All received a standardized muscle-relaxant anaesthetic and dexamethasone 0.1 mg kg -1. The primary outcome was any vomit in the immediate postoperative period. Comparisons were made of the proportion in each group reaching the primary outcome and the time until their first vomit. The study was designed to detect equivalence. Results. The incidence of vomiting in the group receiving ondansetron (25.3%) was 12% lower (95% CI 4.4-19.7) than those in metoclopramide (37.3%). The time until first vomit was significantly longer in the group receiving ondansetron (hazard ratio 0.61, 95% CI 0.45-0.82). Conclusions. Although the incidence of vomiting was similar, when these results are compared with a pre-specified zone of equivalence of 0-15%, it cannot be concluded that the effect of metoclopramide is equivalent to ondansetron. Survival analysis indicated that those in the metoclopramide group vomited substantially earlier. It is concluded, therefore, that ondansetron 0.1 mg kg-1 is a superior drug to metoclopramide 0.5 mg kg-1 for the prophylactic control of POV in children undergoing tonsillectomy.

KW - Anaesthesia, paediatric

KW - Clinical trials

KW - Surgery, otolaryngological

KW - Vomiting, incidence

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U2 - 10.1093/bja/aem236

DO - 10.1093/bja/aem236

M3 - Article

VL - 99

SP - 699

EP - 703

JO - British Journal of Anaesthesia

JF - British Journal of Anaesthesia

SN - 0007-0912

IS - 5

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