The effect of premedication with OTFC, with or without ondansetron, on postoperative agitation, and nausea and vomiting in pediatric ambulatory patients

Wendy Binstock, Rachel Rubin, Cathy Bachman, Madelyn Kahana, William Mcdade, James P. Lynch

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Background: The purpose of this study was to evaluate, in the pediatric ambulatory surgical population, the efficacy of: (i) oral transmucosal fentanyl citrate (OTFC), when given preoperatively, to reduce post-operative excitement associated with sevoflurane, and (ii) intravenous ondansetron to reduce postoperative nausea and vomiting (PONV) associated with OTFC. Methods: This randomized, double-blinded, placebo controlled study evaluated the efficacy of OTFC [normal dose (ND) = 10-15 μg·kg-1 or low dose = 100 μg] compared with placebo in the prevention of postoperative agitation; and the efficacy of ondansetron (0.1 mg·kg-1 to 4 mg) compared with placebo to reduce PONV associated with OTFC. Results: There were 125 patients evaluated (2-10 years old, ASA class I or II and weight 10-40 kg). Preoperatively OTFC was associated with an increased likelihood of cooperation at baseline (P = 0.018). Postoperatively there was a higher incidence of vomiting in children that received OTFC. The anxiety/agitation of patients entering the PACU was significantly less in children who received OTFC ND (P < 0.001). This effect decreased over time. Patients with respiratory adverse events related to the study drug were significantly higher in groups who received OTFC, however, they were not of clinical significance. OTFC was associated with delays in time for eligibility to PACU discharge (P = 0.003). Conclusions: Even though OTFC reduced early postoperative agitation the increase in side effects, namely PONV and prolonged recovery times, limits its clinical usefulness. The study demonstrates the tradeoffs between anxiety and agitation vs vomiting, respiratory events and prolonged recovery times. Ambulatory pediatric patients undergoing procedures in which opioids would be routinely used might benefit the most from OTFC combined with ondansetron as part of the anesthetic technique.

Original languageEnglish (US)
Pages (from-to)759-767
Number of pages9
JournalPaediatric Anaesthesia
Volume14
Issue number9
DOIs
StatePublished - 2004
Externally publishedYes

Fingerprint

Ondansetron
Postoperative Nausea and Vomiting
Premedication
Fentanyl
Pediatrics
Placebos
Vomiting
Anxiety
Opioid Analgesics
Anesthetics

Keywords

  • Anesthesia
  • Emergence
  • Excitation
  • Ondansetron
  • OTFC
  • PONV
  • Sevoflurane

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine
  • Pediatrics, Perinatology, and Child Health

Cite this

The effect of premedication with OTFC, with or without ondansetron, on postoperative agitation, and nausea and vomiting in pediatric ambulatory patients. / Binstock, Wendy; Rubin, Rachel; Bachman, Cathy; Kahana, Madelyn; Mcdade, William; Lynch, James P.

In: Paediatric Anaesthesia, Vol. 14, No. 9, 2004, p. 759-767.

Research output: Contribution to journalArticle

Binstock, Wendy ; Rubin, Rachel ; Bachman, Cathy ; Kahana, Madelyn ; Mcdade, William ; Lynch, James P. / The effect of premedication with OTFC, with or without ondansetron, on postoperative agitation, and nausea and vomiting in pediatric ambulatory patients. In: Paediatric Anaesthesia. 2004 ; Vol. 14, No. 9. pp. 759-767.
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T1 - The effect of premedication with OTFC, with or without ondansetron, on postoperative agitation, and nausea and vomiting in pediatric ambulatory patients

AU - Binstock, Wendy

AU - Rubin, Rachel

AU - Bachman, Cathy

AU - Kahana, Madelyn

AU - Mcdade, William

AU - Lynch, James P.

PY - 2004

Y1 - 2004

N2 - Background: The purpose of this study was to evaluate, in the pediatric ambulatory surgical population, the efficacy of: (i) oral transmucosal fentanyl citrate (OTFC), when given preoperatively, to reduce post-operative excitement associated with sevoflurane, and (ii) intravenous ondansetron to reduce postoperative nausea and vomiting (PONV) associated with OTFC. Methods: This randomized, double-blinded, placebo controlled study evaluated the efficacy of OTFC [normal dose (ND) = 10-15 μg·kg-1 or low dose = 100 μg] compared with placebo in the prevention of postoperative agitation; and the efficacy of ondansetron (0.1 mg·kg-1 to 4 mg) compared with placebo to reduce PONV associated with OTFC. Results: There were 125 patients evaluated (2-10 years old, ASA class I or II and weight 10-40 kg). Preoperatively OTFC was associated with an increased likelihood of cooperation at baseline (P = 0.018). Postoperatively there was a higher incidence of vomiting in children that received OTFC. The anxiety/agitation of patients entering the PACU was significantly less in children who received OTFC ND (P < 0.001). This effect decreased over time. Patients with respiratory adverse events related to the study drug were significantly higher in groups who received OTFC, however, they were not of clinical significance. OTFC was associated with delays in time for eligibility to PACU discharge (P = 0.003). Conclusions: Even though OTFC reduced early postoperative agitation the increase in side effects, namely PONV and prolonged recovery times, limits its clinical usefulness. The study demonstrates the tradeoffs between anxiety and agitation vs vomiting, respiratory events and prolonged recovery times. Ambulatory pediatric patients undergoing procedures in which opioids would be routinely used might benefit the most from OTFC combined with ondansetron as part of the anesthetic technique.

AB - Background: The purpose of this study was to evaluate, in the pediatric ambulatory surgical population, the efficacy of: (i) oral transmucosal fentanyl citrate (OTFC), when given preoperatively, to reduce post-operative excitement associated with sevoflurane, and (ii) intravenous ondansetron to reduce postoperative nausea and vomiting (PONV) associated with OTFC. Methods: This randomized, double-blinded, placebo controlled study evaluated the efficacy of OTFC [normal dose (ND) = 10-15 μg·kg-1 or low dose = 100 μg] compared with placebo in the prevention of postoperative agitation; and the efficacy of ondansetron (0.1 mg·kg-1 to 4 mg) compared with placebo to reduce PONV associated with OTFC. Results: There were 125 patients evaluated (2-10 years old, ASA class I or II and weight 10-40 kg). Preoperatively OTFC was associated with an increased likelihood of cooperation at baseline (P = 0.018). Postoperatively there was a higher incidence of vomiting in children that received OTFC. The anxiety/agitation of patients entering the PACU was significantly less in children who received OTFC ND (P < 0.001). This effect decreased over time. Patients with respiratory adverse events related to the study drug were significantly higher in groups who received OTFC, however, they were not of clinical significance. OTFC was associated with delays in time for eligibility to PACU discharge (P = 0.003). Conclusions: Even though OTFC reduced early postoperative agitation the increase in side effects, namely PONV and prolonged recovery times, limits its clinical usefulness. The study demonstrates the tradeoffs between anxiety and agitation vs vomiting, respiratory events and prolonged recovery times. Ambulatory pediatric patients undergoing procedures in which opioids would be routinely used might benefit the most from OTFC combined with ondansetron as part of the anesthetic technique.

KW - Anesthesia

KW - Emergence

KW - Excitation

KW - Ondansetron

KW - OTFC

KW - PONV

KW - Sevoflurane

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