Cleft Lip and Palate
Conditions
Brief 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
Interventions
DRUGKetorolac
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
DRUGPlacebo
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of oral intake | from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery | This will be measured in mL's of fluids |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale | immediately upon arrival at PACU | This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome |
| Pain as assessed by the Faces scale | 7 days post discharge | Subjective assessment of discomfort by parent, scored from 1-10, higher number indicating a worse outcome |
| Time to first oral intake | within 24 hours post surgery | — |
| Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room | 24 hours and 48 hours after surgery | — |
| Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents) | 7 days post surgery | — |
| Number of participants who need narcotic prescription at discharge | at discharge(24-48 hours post surgery) | — |
| Renal function measured in mL/kg of urine output | from arrival to PACU to discharge (24-48 hours post surgery) | — |
| Number of participants with post operative complications | 30 days post surgery | post operative complications include,Unplanned return to OR, ER or unplanned clinic visit , Infection, Fever |
Countries
United States
Contacts
CONTACTMatthew R Greives, MD,MS,FACS
CONTACTTien Do, DO
PRINCIPAL_INVESTIGATORMatthew R Grieves, MD,MS,FACS
The University of Texas Health Science Center, Houston
Outcome results
None listed