The Effects of Intranasal Fentanyl on Post-operative Pain Relief and Nausea and Vomiting in Children Undergoing Bilateral Myringotomy and Tube Placement

Abstract

In the United States, bilateral myringotomy and tympanostomy (BMT) is the most commonly performed pediatrics surgery with approximately 1 million cases per year. The majority of these procedures are performed on children aged 12 months to 5 years, with mask induction and without the placement of an intravenous catheter. Options for postoperative pain management are limited. Routes of drug administration like oral, rectal, and intramuscular have significantly slower onsets. Recent research has shown administration of intranasal fentanyl to be a promising method of postoperative pain control and agitation. <p>A sentinel study by Finkel et al. showed that 2 mcg/kg of intranasal fentanyl significantly reduced emergence agitation and pain more when compared to a 1 mcg/kg dose in children undergoing bilateral myringotomy and trympanostomy tube placement. While the results on behavior and pain were encouraging, there was a significant increase in nausea in the 2 mcg/kg group as compared with the control group and the 1 mcg/kg group. The study analyzed the effectiveness and side effect of an intermediate dose of fentanyl. The researchers hypothesized that 1.5 mcg/kg of intranasal fentanyl would create similar analgesic and anxiolytic effects as the 2 mcg/kg dose of intranasal fentanyl with a decrease in postoperative nausea. <p>In a postoperative, single blind randomized clinical trial, 34 ASA class I and II children between the ages of 6 months and 5 years, who met inclusion criteria, were placed in one of two groups by random assignment. Legal guardians of prospective study participants received a brief synopsis of the study from a physician's office. On the day of surgery, the prospective subjects were assessed for appropriateness of study inclusion, and if met, guardians were approached for informed consent. The randomly selected envelope indicating group assignment was given to the anesthesia provider. All children were induced by sevoflurane, nitrous oxide, and oxygen via mask. After induction of general anesthesia, group I received 1.5 mcg/kg of intranasal fentanyl, 0.75 mcg/kg per nare, and 30 mg/kg of rectally administered acetaminophen. Group II received 30 mg/kg of rectally administered acetaminophen and intranasal administration of normal saline placebo of equivalent volume to the amount of fentanyl that would have been administered at 1.5 mcg/kg. <p>Upon arrival to PACU, the anesthesia provider delivered the postoperative assessment form to the registered nurse accepting care of the patient. Assessment using the FLACC (Face Legs Activity Cry Consolability) pain scale (Appendix G) or pain interval scale (Appendix H) was performed and documented upon arrival and every 15 minutes until the patient was transferred to the same day surgery unit The assessment forms contained an additional site for inclusion of information on incidence of nausea and vomiting as well as need for rescue medications. The same assessments were performed and documented upon arrival to and discharge from the same day surgery unit. The researchers contacted the parents/legal guardians via telephone 24 to 72 hours after surgery to assess the child’s postoperative analgesic requirements and the incidence of nausea and vomiting. <p>At the end of the study, data was reviewed and analyzed to determine if an intermediate dose of intranasal fentanyl was effective for postoperative pain control without significant occurrence of unwanted side effects. The results showed significantly lower FLACC scores in the 1.5 mcg/kg of fentanyl than the placebo group. There was a 55.3% incidence of nausea and vomiting in the fentanyl group compared to 0% incidence in the placebo group, however the 5.3% difference between the groups was not statistically significant.