NCT04771156

Ketorolac in Palatoplasty

Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if the addition of IV Ketorolac to usual care multi-modal pain therapy compared to usual care will improve oral intake post-operatively

Conditions

• Cleft Lip and Palate

Interventions

Type	Name	Description
DRUG	Ketorolac	Ketorolac 0.5mg/kg will be administered intra-operatively at the conclusion of the case and 3 more doses scheduled every 8 hours in the first 24 hours post-operatively for a total of 4 doses of Ketorolac
DRUG	Placebo	0.9% Normal Saline will be administered intra-operatively at the conclusion of the case and 3 more doses scheduled every 8 hours in the first 24 hours post-operatively for a total of 4 doses of normal saline.

Timeline

• Start date: 2021-09-17
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2021-02-25
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study