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Oral transmucosal fentanyl citrate for premedication in paediatric outpatients
M A Ashburn1, J B Streisand, S D Tarver
1Department of Anesthesiology, Primary Children's Hospital, Salt Lake City, Utah.
Insights
Oral transmucosal fentanyl citrate (OTFC) effectively sedated and reduced anxiety in children undergoing surgery. However, OTFC delayed oral fluid tolerance and hospital discharge compared to placebo.
Area of Science:
- Anesthesiology
- Pediatric Surgery
- Pharmacology
Background:
- Premedication in pediatric surgery aims to reduce anxiety and facilitate anesthesia induction.
- Oral transmucosal fentanyl citrate (OTFC) is an option for procedural sedation and analgesia.
- Optimizing pre-anesthetic protocols in children is crucial for patient comfort and hospital efficiency.
Purpose of the Study:
- To evaluate the efficacy and safety of two doses of oral transmucosal fentanyl citrate (OTFC) as a premedicant in healthy children undergoing short surgical procedures.
- To compare the effects of OTFC on sedation, anxiolysis, recovery, and postoperative outcomes against a placebo.
- To assess the impact of OTFC on time to tolerate oral fluids and hospital discharge.
Main Methods:
- A randomized, double-blind, placebo-controlled study involving 105 healthy children aged 2-13 years.
- Children received either two doses of OTFC (10-15 mcg/kg or 15-20 mcg/kg) or a placebo.
- Most participants also received IV droperidol post-anesthesia induction; anesthesia was induced with halothane and N2O.
Main Results:
- Both OTFC doses significantly improved sedation and anxiolysis compared to placebo.
- Postoperative analgesic requirements were lower in the lower OTFC dose group versus placebo.
- OTFC groups experienced delayed oral fluid tolerance, leading to longer hospital discharge times (30-50 minutes).
- Preoperative pruritus was significantly more frequent in OTFC groups.
Conclusions:
- Oral transmucosal fentanyl citrate (OTFC) is a safe and effective premedicant for pediatric patients undergoing short operations, providing significant sedation and anxiolysis.
- While effective, OTFC can delay hospital discharge due to delayed oral fluid tolerance in the postoperative period.
- Further research may explore strategies to mitigate delayed fluid tolerance and optimize discharge timing with OTFC use.
Abstract:
Two doses (10-15 micrograms.kg-1, Group I, and 15-20 micrograms.kg-1, Group II) of oral transmucosal fentanyl citrate (OTFC) plus a placebo (Group III) were evaluated for premedication in 105 healthy children, aged 2 to 13 yr, undergoing short (less than 1 hr) operations in the hospital short-stay unit. The study was randomized and double-blinded and 91 of the 105 children also received droperidol, 25 micrograms.kg-1 IV, after induction of anaesthesia with halothane and N2O in oxygen. Both doses of OTFC produced significantly greater sedation (first present at 20 min) and anxiolysis (first present in Group I at 40 min) than the placebo. Recovery times were similar in the three groups and analgesic requirements in the recovery room were significantly lower in Group I than Group III. Both OTFC groups took longer to tolerate oral fluids in the postoperative discharge unit than the placebo group and this caused patients in Group I to have a delayed discharge from the hospital compared to Group III. Preoperative pruritus occurred significantly more frequently in Groups I and II (58 and 76 per cent, respectively) than Group III (23 per cent). Although the incidences of nausea and vomiting tended to be slightly higher in the OTFC groups in the preoperative holding and postoperative discharge units, the differences among the groups were not statistically significant. Likewise droperidol did not reduce the incidence of postoperative nausea or vomiting. The data indicate that OTFC may be a safe and effective premedicant in paediatric patients having short operations but delays discharge from the hospital (by 30-50 min) by delaying the time patients tolerate fluids early after operation.