Efficacy And Safety Of Single-dose Ketorolac In Primary Palatoplasty: A Prospective Analysis
Jason R. Stein, B.S1, Esperanza Mantilla-Rivas, M.D1, Marudeen Aivaz, B.S1, Sohel Rana, MBBS, MPH2, Ishwarya Mamidi, B.S1, Brynne Ichiuji, B.A1, Monica Manrique, M.D1, Justin R. Bryant, D.O., MBA1, Gary F. Rogers, M.D., J.D., LL.M., M.B.A., M.P.H1, Albert K. Oh, M.D1.
1Children's National Hospital, George Washington University School of Medicine, Washington, DC, USA, 2Joseph E. Robert, Jr., Center for Surgical Care, Children’s National Hospital,, Washington, DC, USA.
PURPOSE: Early postoperative concerns after palatoplasty (PP) include airway compromise, hemorrhage, and pain. Optimal protocols for postoperative pain management have not been well studied in this population. In other clinical scenarios, Ketorolac has demonstrated efficacy comparable to opioids with minimal adverse effects. Nevertheless, potential risk for increased postoperative bleeding may limit its use. This prospective study analyzes the efficacy and safety of single-dose ketorolac for postoperative pain control in PP.
METHODS: We prospectively studied a consecutive cohort of patients undergoing PP at a single institution with two surgeons having subspecialty training in craniofacial/pediatric plastic surgery. Subjects were classified into two groups: Group 1 was treated with standard doses of acetaminophen and narcotics while Group 2 received an additional single immediate postoperative dose of ketorolac. Efficacy of ketorolac was assessed through bleeding, FLACC pain score and narcotics dose using multivariable linear regression, Fisher’s exact test, and Poisson regression.
RESULTS: 100 patients were included (Group 1 n=63; Group 2 n=37). No significant differences were noted in administration of Ketorolac between surgeons. There was no significant difference between median length of stay (LOS) for both groups (Group 1 median of 38.5 hr (95% CI 33.6, 43.3) vs. Group 2 has a median of 37.6 hr (95% CI 31.3, 44.0), p=0.84). During hospitalization, nine patients had oxygen saturation below 93% and received postoperative blow-by O2, 3 (4.8%) from Group 1 and 2 from Group 2 (5.4%; p>0.99). There was no significant difference in initial, 6-hour, or LOS FLACC score (p>0.05). Out of 100 patients, 74% received narcotic medications. The mean dose of opioid rescue medication measured as morphine milligram equivalents (MME) did not differ between groups (p=0.40). Significant postoperative hemorrhage was not observed in either group.
CONCLUSION: This study demonstrated that while a single-dose of ketorolac after PP did not result in increased risk for postoperative hemorrhage, it did not provide more effective analgesia compared to the standard doses of acetaminophen and narcotics.
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