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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.