Oral Transmucosal Fentanyl Pretreatment: RESULTS

In: Anesthesia

27 Jan 2010

Thirty-three children were enrolled into this study during the week prior to the oral rehabilitation appointment. On the day of the general anesthetic/dental restoration appointment, 2 parents withdrew consent, 2 children refused to accept the OTFC lozenge, 2 children had baseline sedation scores of 3 (calm), and 1 child chewed and swallowed the formulation immediately. Eliminating these 7 subjects (2 placebo and 5 active) provided complete records for 26 children (Table 1). Only two subjects weighed more than the 25 kg, thereby requiring assignment to the 300-330 randomized coded strata. These children, 1 male and 1 female, were combined with the subjects receiving the 200-230 coded strata (200 |xg OTFC or placebo) for the efficacy and safety analyses. Age, gender, and weights of the 2 groups were comparable. The 1 subject with an ASA physical status II had a history of bronchial asthma. The drug allergy histories consisted of 3 reported reactions to penicillin, 2 to cephalosporins, 1 to codeine, and 1 to acetaminophen.

Table 1. Demographics of Study Population

Subjects Placebo Group Fentanyl Group
No. 9 17
Sex 5 males/4 females 9 males/8 females
Age 3.7 (±0.2)
Mean years (± se) 3.7 (±0.3)
Range of years 2-5 years 3-5 years
Weight 16.7 (±0.5)
Mean kilograms (±se) 17.8 (±0.7)
ASA physical status
PS I 9 16
PS II 0 1
Positive history of drug allergies 1 6

Table 2 summarizes the characteristics of the anesthetic procedures for the 2 groups. The time between administration of the OTFC and removal (or completion) ranged between 10 and 30 minutes. There were no significant differences between treatments with regard to the duration of surgery or time of recovery. General anesthesia was most often induced using a mask induction technique with halothane and nitrous oxide. Maintenance drugs varied greatly between children, making comparisons of anesthetic drug requirements between treatments impossible. Nineteen of the 26 cases included fentanyl within the general anesthetic drug regimen. kamagra tablets

Table 2. Sedation and Anesthetic Characteristics

Variable Placebo Group (n=9) Fentanyl Group (n =17)
Intubation success
Successful on first attempt 8 11
2 or more attempts 1 6
Duration of surgery/dental rehabilitation
Mean (±se) 116 (±13) min 103 (±9) min
Recovery time
Mean (±se) 56 (±9) min 66 (±6) min

The behavior ratings for sedation (5-point scale), separation (4-point scale), and cooperation with a mask induction (3-point scale) are provided in Table 3. Both fentanyl and placebo treatment groups showed slight improvement during the preanesthetic period. The active OTFC group of children was found to have statistically significant improvements in behavior for parental separation and cooperation with induction.

Table 3. Behavioral Responses to OTFC Premedication

Variable Placebo Group (n =9) Fentanyl Group (n =17)
Sedation in waiting room (5 point scale)
Baseline P = ns
Rating of 1 0 0
Rating of 2 0 0
Rating of 3 0 0
Rating of 4 7 (78%) 14 (82%)
Rating of 5 2 (22%) 3 (18%)
10 minutes P = ns
Rating of 1 0 0
Rating of 2 0 0
Rating of 3 3 (33%) 7 (41%)
Rating of 4 5 (55%) 10 (59%)
Rating of 5 1 (11%) 0
20 minutes P = ns
Rating of 1 0 0
Rating of 2 0 4 (24%)
Rating of 3 4 (44%) 6 (35%)
Rating of 4 0 7 (41%)
Rating of 5 5 (56%) 0
Separation from parent (4 point scale) P < 0.05
Rating of 1 2 (22%) 7 (41%)
Rating or 2 1 (11%) 6 (35%)
Rating of 3 3 (33%) 2 (12%)
Rating of 4 3 (33%) 2 (12%)
Cooperation with induction (3 point scale) P < 0.05
Rating of 1 1 (11%) 5 (29%)
Rating of 2 0 6 (35%)
Rating of 3 8 (89%) 6 (35%)

Table 4 delineates side effects and complications reported for the fentanyl and placebo treatments. Although cardiovascular, respiratory, and gastrointestinal events occurred more frequently in the active group, the incidence rates for these reactions were not statistically higher than the placebo group. Two children receiving the active OTFC had mild desaturations, corrected by repositioning and increasing oxygen flows. One other child in the active treatment group, weighing 19 kg, developed moderately severe respiratory depression 75 minutes following induction of general anesthesia (oxygen desaturation < 85%). The anesthetic regimen for this child included nitrous oxide, halothane, glycopyr-rolate (75 |xg), mivacurium (5 mg), and fentanyl (250 fxg). Naloxone (40 |xg) was administered and respiratory rates and 02 saturations returned to normal.
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Table 4. Side Effects and Complications

Variable Placebo Group (n =9) Fentanyl Group (n = 17)
Respiratory (desaturations < 95%)
Not requiring drug therapy 0 2 (11.8%)
Requiring drug therapy 0 1 (5.9%)
Cardiovascular
Arrythmias 0 0
Bradycardia 0 2 (11.8%)
Other:
Nausea/vomiting 0 1 (5.9%)
Shivering 1 (11.0%) 2 (11.8%)
Total subjects with any adverse reactions
1/9 (11.0%) 6/17 (35.3%)**
** n (%)** Two subjects had more than one adverse event.

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