Recruiting NCT04771156
Ketorolac in Palatoplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketorolac, Placebo.
- Who it may be relevant to
- Registry conditions: Cleft Lip and Palate. Basic parameters: from 6 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.
Overview
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
Interventions
- 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.
Primary outcome measures
- Volume of oral intake [Time frame: from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery]
Secondary outcome measures (10)
- Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale [Time frame: immediately upon arrival at PACU]
- Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale [Time frame: 24 hours post surgery]
- Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale [Time frame: 48 hours post surgery]
- Pain as assessed by the Faces scale [Time frame: 7 days post discharge]
- Time to first oral intake [Time frame: within 24 hours post surgery]
- Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room [Time frame: 24 hours and 48 hours after surgery]
- Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents) [Time frame: 7 days post surgery]
- Number of participants who need narcotic prescription at discharge [Time frame: at discharge(24-48 hours post surgery)]
- Renal function measured in mL/kg of urine output [Time frame: from arrival to PACU to discharge (24-48 hours post surgery)]
- Number of participants with post operative complications [Time frame: 30 days post surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT04771156 · HSC-MS-21-0044