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

Abstract

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. Setting: 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], P = .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 ( P = .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.

Postoperative Use of Ketorolac Improves Pain Management and Decreases Narcotic Use Following Primary Cleft Palate Surgery

“…Because bleeding is such a rare event in cleft palate surgery, a larger sample size would be required to prove any significant difference between the ketorolac and nonketorolac groups. The Stein et al (2021) study also found no differences in bleeding between their ketorolac and nonketorolac groups. Our results add further evidence to support the safety of ketorolac use in cleft palate surgery.…”

“…This reached statistical significance with a P -value of <.001. A similar study investigating a single IV dose of ketorolac following their procedure (Stein et al, 2021) did not find this significant decrease in narcotic usage. This could be related to the difference in intervention protocols, as our study administered IV ketorolac intraoperatively and postoperatively and their protocol involved administration of a single dose of IV ketorolac postop.…”

“…However, it is also possible that this result indicates decreased pain during hospitalization in the infants of the ketorolac group compared to those in the nonketorolac group. Stein et al (2021) also used the FLACC score to evaluate ketorolac's analgesic efficacy and found no significant difference between the groups. Again, this score is difficult to compare across institutions, or even time periods, because of its inherent subjectivity.…”

“…It found no increased bleeding events among the 50 patients in the multimodal ketorolac group. Stein et al (2021) was the only article we found that attempted to examine the effects of ketorolac on postoperative pain control after cleft palate surgery. They found that a single dose of IV ketorolac after a primary palatoplasty was safe and effective, as no significant postop hemorrhage occurred and Face, Legs, Activity, Cry, Consolability (FLACC) scores were similar between groups.…”

Patient Safety and Quality Improvement Initiatives in Cleft Lip and Palate Surgery: A Systematic Review

“…Many of the included studies investigated the use of various analgesia techniques that aimed at reducing postoperative opioid consumption. 2,[14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] Seven of the included studies investigated the effectiveness of bupivacaine for use in nerve block in cleft lip and/ or palate repair. 1,4,28,[30][31][32][33] All but 1 1 focused on infraorbital nerve block placement in cleft lip surgery patients.…”