Ketorolac in Palatoplasty

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Cleft Lip and Palate

Treatments: Drug: Placebo; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT04771156

HSC-MS-21-0044

Details and patient eligibility

About

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

Enrollment: 74 estimated patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral

Exclusion criteria

• Syndromic Cleft Palate patients
• Previous palatoplasty
• Major unrepaired cardiac malformation
• History of GI complications (GI Bleed, Gastric Ulceration)
• History of Renal disorder
• History of coagulopathy (As contraindication to NSAID use)
• Feeding tube dependency
• Patients whose parents refuse to consent to randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups, including a placebo group

Experimental group (Ketorolac)

Experimental group

Treatment:

Drug: Ketorolac

Control Group

Placebo Comparator group

Treatment:

Drug: Placebo