2024 FSA Podium and Poster Abstracts
S001: COMPARISON OF EMERGENCE AGITATION AND PAIN SCORES IN PEDIATRIC PATIENTS UNDERGOING EAR-NOSE-THROAT PROCEDURES UTILIZING OPIOID-ONLY ANALGESIA OR OPIOID ANALGESIA WITH EITHER IV OR ORAL ACETAMINOPHEN: A RANDOMIZED MULTI-CENTER DOUBLE-BLINDED STUDY
Carlos Archilla, MD, MBA; Robert Bryskin, MD; Tim Maul, CCP, FPP, PhD; Nemours Children's Health
Background: Emergence Agitation (EA) is a state of aggressive agitation that occurs during the early stages of emergence from anesthesia. Data regarding the impact of different analgesic modalities on occurrence of EA in children following sevoflurane-based anesthesia is scarce, and results are far from uniform. Acetaminophen is the most common analgesic adjunct in pediatric patients. Advent of IV formulation of acetaminophen raises the question of whether one preparation may decrease incidence of EA in children undergoing tonsillectomy and/or adenoidectomy.
Methods: We designed a prospective, multi-center, double-blind, placebo controlled, randomized study to examine potential differences in incidence of EA and postoperative pain scores among three different perioperative analgesic regimens. After IRB approvals and obtaining an FDA Investigational New Drug application (IND 135040) for a proposed indication of emergence agitation for IV acetaminophen, we enrolled patients between the ages of 2 through 7, undergoing adenoidectomy and/or tonsillectomy. Sevoflurane was used for induction and maintenance of anesthesia. Subjects were randomized between three groups: Group A: Analgesia of IV fentanyl plus IV and oral placebo: Group B: Analgesia of IV fentanyl plus IV acetaminophen and PO placebo: Group C: Analgesia of IV fentanyl plus PO acetaminophen and IV placebo. The clinical and research staff was limited and blinded. Pain was assessed using FLACC Scale for age 2 to 4 years and sedated patients, Wong-Baker FACES visual scale for patients 4 to 7 years and non-verbal patients, and Numeric Pain Score for patients ≥7 years. EA was measured using the standardized Pediatric Anesthesia Emergence Delirium Scale.
Results: One hundred forty-three patients were randomized and completed the study at two centers. Patients enrolled in the study (74 female, 69 male; age 4.7 ± 1.5 years; weight 20.9 kg ± 5.7) were not fundamentally different between groups. In terms of primary outcomes, there was no difference between groups in terms of mean (p=0.051) or max PAED scores (p=0.35). There was no statistical difference in the mean pain scores when comparing the Opioid versus the Opioid Plus Acetaminophen group (p=0.98) or in the PO versus the IV Acetaminophen subgroups (p= 0.68). There was no statistical difference between the three arms in terms of max pain scores (p= 0.95).
In terms of secondary outcomes, there was no statistical difference in the number of subjects experiencing EA (PAED Score ≥ 12 at any of the 15-minute intervals) between the three study arms (p=0.52). There was no difference in the incidence of adverse events in the three groups.
An observed 19% reduction in postoperative fentanyl consumption was observed in the Opioid plus IV Acetaminophen group compared to the Opioid plus PO acetaminophen group but was found not to be statistically significant (p=0.34).
Conclusions: With the data collected, we conclude that there is no clear advantage to the addition of acetaminophen in either oral or IV route in the perioperative period for reduction of mean PAED scores, or reduction of the mean pain scores, or reduction of dosing for opioids in the PACU for the surgeries performed.