Oral Transmucosal Fentanyl Pretreatment: MATERIALS AND METHODS

In: Anesthesia

26 Jan 2010

Thirty-three young children, scheduled for outpatient general anesthesia to permit treatment of dental caries, were enrolled in this randomized controlled clinical trial. Seven to 10 days prior to the rehabilitation appointment, the parent or guardian was invited to have their child participate in the study and, if willing, to sign the Institutional Review Board (IRB) approved informed consent form. On the day of the treatment appointment, the parent’s willingness to have their child participate was confirmed.

In the waiting room 30 minutes prior to the start of anesthesia, each child, while in the presence of a parent/guardian, received either an oral lozenge containing the recommended dose of fentanyl (5-15 |xgAg) or a placebo lozenge. The placebo was provided by the manufacturer and was packaged and formulated to have an identical taste and appearance. The active and placebo formulations were packaged in sealed envelopes and coded for random assignment. The OTFC dose used in this study followed the manufacturer’s weight-based recommendations: <15 kg, contraindicated; 15-25 kg, 200 |mg, and 25-35 kg, 300 jig. The study design called for three equal-sized treatment groups (placebo, OTFC 200 jig, and OTFC 300 |xg). Random codes were stratified for the child’s weight as follows: children weighing 15-25 kg were assigned to a random code numbered 200-230 (20 active drug and 10 placebo) and children weighing 25-35 kg were assigned to a random code numbered 300-330 (20 active drug and 10 placebo). Because enrollment in the higher dose group was limited, the active treatments were combined and the final analysis was based on only 2 groups.
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Following OTFC administration, children were monitored in the waiting room with a pulse oximeter. The children were permitted to consume the lozenge at their own rate unless oversedation or significant oxygen de-saturations were apparent. Thirty minutes following test drug administration, the child was brought into the anesthesia suite for administration of general anesthetic using mask induction.

Inclusion criteria for this study included the following:

(1)  both male and female children 24-60 months of age,
(2)  body weights of 15-35 kg,
(3)  children scheduled for general anesthesia for restoration of 2 or more teeth,
(4)  baseline sedation score behaviors of alert (4) or agitated
(5) as shown below. (Because children who display more acceptable behaviors such as asleep [1], drowsy [2], or calm [3] would not be routinely premedicated in our clinic, these subjects were not to be enrolled in this study of OTFC.) Exclusion criteria included the following:

(1) systemic illness that increases the risk of outpatient
anesthesia (ie, ASA physical status III or greater),
(2) parents or guardians unwilling or unable to participate in consent and data collection procedures,
(3) chronic use of CNS depressants or antidepressants,
(4) ingestion of benzodiazepine, narcotic, or barbiturate in the preceding 24 hours,
(5) active infection with systemic symptoms,
(6) medical history contraindicating outpatient general anesthesia or the administration of opioids. canadian antibiotics

The child’s level of anxiety and cooperation was assessed using the Clinical Evaluation Protocol for Pediatric Premedication Prior to Anesthesia that accompanied the manufacturer’s package insert. Scoring was completed by one of the staff dentist anesthesiologists in charge of the case. Practice sessions were provided for these study members (MAC, JAM, ACC, AHC, and LAW) to promote reliability between raters. Three behavioral outcome ratings were used:
(1) sedation score (in waiting room prior to OTFC and
10 and 20 minutes after OTFC)
1 = asleep (does not respond to verbal or minor
physical stimulation)
2 = drowsy (eyes closed, responds to verbal or minor physical stimulation)
3 = calm (relaxed, sitting, or lying with eyes open)
4 = alert (awake, not clinging to parent, may
whimper but is not crying)
5 = agitated (clinging to parent, crying)
(2) separation score (from parent to anesthesia care
provider for transport to the operatory)
1 = excellent (unafraid, cooperative, or asleep)
2 = good (slight fear and/or limited whimpering,
quiet when provided with reassurance)
3 = fair (moderate fear and/or crying, not quiet
when provided with reassurance)
4 = poor (crying, need for restraint)
(3) cooperation score (for mask induction)
1 = cooperative (accepts mask without resistance)
2 = mildly resistant (requires minimum or no restraint)
3 = resistant (requires active restraint of hands
and/or legs)

The anesthesia record provided the following data: (1) appropriate use and completion of the OTFC, (2) number of intubation attempts, (3) duration of surgery (start and finish times), (4) doses of all general anesthetic agents, (5) incidences of side effects, (6) oxygen desat-urations <95%, and (7) recovery time. Our clinic’s normal discharge criteria for alertness and responsiveness to verbal stimuli were employed. Parents were contacted by telephone in the evening following anesthesia and asked about the child’s activities, meals, and incidence of nausea or vomiting. All evaluations were provided by study personnel who were blinded to the treatment assignments. The demographic (age, weight) and anesthetic characteristics (duration, recovery time) for the active and placebo OTFC groups were tabulated and compared using a Student’s t test. Categorical, behavioral rating, and incidence data were assessed using contingency tables and chi-square statistics.

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