DOI: 10.1097/00000539-199902001-00287
,
Issn Print: 0003-2999
Publication Date: 1999/02/01
Facebook
Twitter
LinkedIn
Email
 |
Checking for direct PDF access through Ovid | |
Excerpt
Rapid emergence from general anesthesia may contribute to postoperative agitation in the pediatric population. [1] We hypothesized that premedication might significantly reduce this side effect. Clinical studies suggest that oral transmucosal fentanyl citrate (OTFC) is a safe and effective premedication in pediatric outpatients. [2] We sought to determine whether OTFC would reduce postoperative agitation associated with sevoflurane and whether ondansetron would reduce the incidence of PONV associated with OTFC.
METHODS: After JRB approval and written informed consent from a parent or guardian, ambulatory patients 2-10 yr old (weight, 10-40 kg; ASA class I or II) were enrolled in a double-blind, placebo-controlled trial. Patients were randomly assigned to 1 to 5 groups:
Group 1=Normal dose OTFC (10-15[micro sign] g/kg); i.v. ondansetron
Group 2=Normal dose OTFC (10-15 [micro sign] g/kg); i.v. placebo
Group 3=Placebo oralet and i.v. ondansetron'
Group 4=Placebo oralet and i.v. placebo
Group 5=Low dose OTFC (100[micro sign]g) and i.v. placebo
All groups received sevoflurane for induction and maintenance. Preoperatively, an independent "blinded" observer evaluated patients for the following: anxiety; sedation; respiratory rate; SaO2; nausea and vomiting; pruritus; and cooperation. A minimum of 25 cc/kg of i.v. fluids was given intraoperatively. During recovery, the observer monitored pain, pain medications and adverse events in addition to the factors evaluated preoperatively. A respiratory adverse event was defined as SaO (2) <90% or RR<10 breaths/min. Fisher's exact test was used to compare proportions of patients having events across groups. Multivariate logistic regression was used to analyze postoperative anxiety/agitation. Times to events were compared using the log rank test. P<.05 was considered statistically significant.
RESULTS: There were 125 patients evaluated. Groups did not differ with respect to gender, weight, age, ASA class, type of surgery, or PNO time. In the preoperative period, OTFC was associated with an increased likelihood of cooperation at baseline (P=0.018). In the postoperative period there was a higher incidence of vomiting in Group 2. The anxiety/agitation of patients entering the PACU was significantly less in Groups 1 and 2 (P<0.001). This effect decreased over time, lasting until approximately 90 min after entrance to the PACU (Table 1). The proportion of patients with respiratory adverse events related to the study drug differed across the groups: Group 1, 26%; Group 2, 22%; Groups 3 and 4, none; Group 5, 4% (P<0.01). OTFC was associated with delays in time to eligibility to PACU discharge (P=0.0006) and time to hospital discharge (P=0.0025).
CONCLUSIONS: OTFC was effective in reducing postoperative agitation associated with sevoflurane, and ondansetron reduced PONV associated with OTFC. This study demonstrates the tradeoffs between anxiety and agitation versus vomiting and respiratory events. Overall, pediatric ambulatory patients undergoing procedures in which opioids would routinely be used might benefit the most from OTFC combined with ondansetron as part of the anesthetic technique.
