Oral Transmucosal Fentanyl Pretreatment: DISCUSSION

In: Anesthesia

28 Jan 2010

Transmucosal fentanyl

Clinical onset of sedation following OTFC administration was found to occur within 10-20 minutes. Monitoring clinical onset of sedation is advantageous because it permits the anesthesia care provider to remove the unused lozenge and to avoid potential oversedation. This attribute distinguishes OTFC from an injection or an oral sedative, where none of the drug dose can be recovered after administration.

The children in both the placebo and active treatment groups had improved sedation scores in the waiting room. Although this was not a statistically significant finding, it does suggest that there is a benefit to establishing a positive relationship between child and provider. The use of either the placebo or active lozenge provides a favorable experience by soothing and quieting the child. As one might expect, this level of placebo sedation did not improve separation ratings as dramatically as in the fentanyl group. kamagra soft tablets

Providing safe and effective premedication in pediatric dentistry has been a challenging issue for decades. Similar to previous reports, we found the OTFC to be well accepted by most of our young patients. Only two children in the current study refused to cooperate with the dentist anesthesiologist and accept the use of the formulation. However, uncooperative children can potentially cause a sedation failure with any premedication administered by the oral route. It is imperative for dental practitioners to have an alternative plan to manage a child’s anesthetic needs when patient acceptance is absent.

This study limited its evaluation of OTFC efficacy to children rated alert or agitated (sedation score of 4 or 5) prior to administration. Only 3 of the children in the active group were rated 5. Had the sample size been larger and had the children been evenly distributed in the level of preoperative anxiety, efficacy specific to pre-treatment behavior could have been evaluated. The OTFC premedication may provide more predictable and pronounced sedation in mildly anxious children but may not be a strategy suitable for severely anxious pediatric patients. Larger studies that stratify treatment groups for preoperative anxiety behavior are needed.

The one oxygen desaturation event requiring drug therapy was an intraoperative event associated, in part, with the administration of additional amounts of intra venous fentanyl for supplementation of the anesthesia. Respiratory depression has been previously reported for OTFC as well as other pediatric sedation procedures using opioids. Clearly, the use of opioids in pediatric sedation regimens requires careful and continuous monitoring of respiratory function. Postoperative nausea and vomiting was also reported but may not be attributed entirely to the OTFC. Postoperative nausea and vomiting can be expected in children undergoing general anesthesia, especially with dental procedures where there is a risk of swallowing blood following oral surgery.


This small placebo-controlled clinical trial evaluated the efficacy and safety of oral transmucosal fentanyl citrate (OTFC) for sedation prior to general anesthesia in 24-60-month-old children. The OTFC formulation was generally well accepted by the children studied. The active OTFC provided moderate improvement in the child’s behavior for separation from the parent and for acceptance of the mask induction of general anesthesia. The duration of surgery and the time of recovery did not differ between placebo and active OTFC premedication. The more frequent side effects seen in the active fentanyl group, including respiratory depression, reinforces the need to carefully monitor children who are deeply sedated with opioids.
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Blog invites submissions of review articles, reports on clinical techniques, case reports, conference summaries, and articles of opinion pertinent to the control of pain and anxiety in dentistry.