Related Experiment Video
Updated: Nov 7, 2025
An Experimental Paradigm for the Prediction of Post-Operative Pain PPOP
Published on: January 27, 2010
Safety and Efficacy of Single-Dose Ketorolac for Postoperative Pain Management After Primary Palatoplasty: A
Jason R Stein1, Esperanza Mantilla-Rivas1, Marudeen Aivaz1
1Division of Plastic and Reconstructive Surgery, Children's National Hospital, Washington, DC, USA.
Insights
A single dose of ketorolac after primary palatoplasty (PP) was found to be safe, with no significant increase in bleeding complications or need for oxygen. Further research is needed to confirm its pain-relieving effects.
Area of Science:
- Pediatric Surgery
- Anesthesiology
- Pharmacology
Background:
- Primary palatoplasty (PP) is a surgical procedure to repair cleft palate.
- Effective pain management is crucial for optimal recovery after PP.
- Non-steroidal anti-inflammatory drugs (NSAIDs) like ketorolac are commonly used for pain relief.
Purpose of the Study:
- To evaluate the safety and efficacy of a single dose of ketorolac in pediatric patients undergoing primary palatoplasty.
- To assess ketorolac's impact on postoperative bleeding, pain scores, and opioid requirements.
Main Methods:
- A prospective cohort study involving 111 patients undergoing PP.
- The study group (n=47) received a single intraoperative dose of ketorolac (0.5 mg/kg) in addition to standard care.
- A historical control group (n=64) received standard care without ketorolac.
- Safety outcomes included bleeding complications and need for oxygen; efficacy was measured by Face Legs Activity Cry Consolability (FLACC) scale and opioid use.
Main Results:
- No significant differences in length of stay between the ketorolac group and the control group.
- Postoperative FLACC pain scores and mean opioid rescue medication doses were similar between groups.
- No significant postoperative hemorrhage was observed in either group.
Conclusions:
- A single intraoperative dose of ketorolac following primary palatoplasty is safe in pediatric patients.
- The study did not demonstrate a significant analgesic benefit, possibly due to study design limitations.
- Further research with larger cohorts and varied postoperative regimens is recommended to clarify ketorolac's role in pain management after PP.
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.
