Ketorolac in Palatoplasty

Study Overview
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Brief Summary
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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

Official Title
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Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (Ketorolac)<br> | Drug: Ketorolac<br>* 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<br>|
| Placebo Comparator: Control Group<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | post operative complications include,Unplanned return to OR, ER or unplanned clinic visit , Infection, Fever | 30 days post surgery |