Safety and Efficacy of Single-Dose Ketorolac for Postoperative Pain Management After Primary Palatoplasty: A Prospective Cohort Study With Historical Controls

Document Type

Journal Article

Publication Date



The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association








FLACC; NSAID; cleft lip; cleft palate; efficacy; ketorolac; pain; palatoplasty; safety


OBJECTIVE: To analyze safety and efficacy of single-dose ketorolac after primary palatoplasty (PP). DESIGN: Consecutive cohort of patients undergoing PP, comparing to historical controls. A large academic children's hospital. PATIENTS, PARTICIPANTS: A consecutive cohort of 111 patients undergoing PP (study n = 47) compared to historical controls (n = 64). INTERVENTIONS: All patients received intraoperative acetaminophen, dexmedetomidine, and opioids while the study group received an additional single dose of ketorolac (0.5 mg/kg) at the conclusion of PP. MAIN OUTCOME MEASURES: Safety of ketorolac was measured by significant bleeding complications and need for supplementary oxygen. Efficacy was assessed through bleeding, Face Legs Activity Cry Consolability (FLACC) scale, and opioid dose. RESULTS: Length of stay was similar for both groups (control group 38.5 hours [95% CI: 3.6-43.3] versus study group 37.6 hours [95% CI: 31.3-44.0], = .84). There were no significant differences in all postoperative FLACC scales. The mean dose of opioid rescue medication measured as morphine milligram equivalents did not differ between groups ( = .56). Significant postoperative hemorrhage was not observed. CONCLUSIONS: This is the first prospective study to evaluate the safety and efficacy of single-dose ketorolac after PP. Although lack of standardization between study and historical control groups may have precluded observation of an analgesic benefit, analysis demonstrated a single dose of ketorolac after PP is safe. Further investigations with more patients and different postoperative regimens may clarify the role of ketorolac in improving pain after PP.


Anesthesiology and Critical Care Medicine