Ketorolac in Palatoplasty

Purpose

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

Condition

  • Cleft Lip and Palate

Eligibility

Eligible Ages
Over 6 Months
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Experimental group (Ketorolac)
  • 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
Placebo Comparator
Control Group
  • 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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Matthew R Greives, MD,MS,FACS
713-500-7275
Matthew.R.Greives@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Matthew R Greives, MD,MS,FACS
(713) 500-7275
Matthew.R.Greives@uth.tmc.edu