Cleft Lip and Palate Clinical Trial
Official title:
Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.
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
Status | Recruiting |
Enrollment | 74 |
Est. completion date | April 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Volume of oral intake | This will be measured in mL's of fluids | from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery | |
Secondary | Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale | This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome | immediately upon arrival at PACU | |
Secondary | Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale | This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome | 24 hours post surgery | |
Secondary | Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale | This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome | 48 hours post surgery | |
Secondary | Pain as assessed by the Faces scale | Subjective assessment of discomfort by parent, scored from 1-10, higher number indicating a worse outcome | 7 days post discharge | |
Secondary | Time to first oral intake | within 24 hours post surgery | ||
Secondary | Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room | 24 hours and 48 hours after surgery | ||
Secondary | Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents) | 7 days post surgery | ||
Secondary | Number of participants who need narcotic prescription at discharge | at discharge(24-48 hours post surgery) | ||
Secondary | Renal function measured in mL/kg of urine output | from arrival to PACU to discharge (24-48 hours post surgery) | ||
Secondary | Number of participants with post operative complications | post operative complications include,Unplanned return to OR, ER or unplanned clinic visit , Infection, Fever | 30 days post surgery |
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