Ketorolac in Palatoplasty

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT04771156
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cleft Lip and Palate

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketorolac — DRUG
    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
  • Placebo — DRUG
    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.

Study Details

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

Key Dates

Start date
Sep 17, 2021
Status verified
Feb 2026
Primary completion
Mar 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group (Ketorolac)
  • Placebo Comparator: Control Group

Primary Outcome Measure

Volume of oral intake [ Time Frame: from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Matthew R Greives, MD,MS,FACS
[email protected]
713-500-7275
Tien Do, DO
[email protected]

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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