Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04771156
Other study ID # HSC-MS-21-0044
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 17, 2021
Est. completion date April 30, 2024

Study information

Verified date December 2023
Source The University of Texas Health Science Center, Houston
Contact Matthew R Greives, MD,MS,FACS
Phone (713) 500-7275
Email Matthew.R.Greives@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05876169 - How Does Orthognathic Surgery Affect Jaw and Neck Motor Function? N/A
Recruiting NCT04455035 - DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants N/A
Not yet recruiting NCT05031039 - Skeletal and Dental Maturational Stages in a Sample of Egyptian Subjects With Cleft Lip and Palate Deformity
Recruiting NCT03839290 - Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty
Completed NCT04725370 - Characterization of Cleft Lip and Palate Conditions in Guatemala
Enrolling by invitation NCT02702869 - Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)
Active, not recruiting NCT05971914 - Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft N/A
Completed NCT03708406 - Otologic and Rhinologic Outcomes in Children With Clef Palate
Recruiting NCT06105099 - Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate N/A
Completed NCT06075069 - Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function N/A
Completed NCT04384276 - Weigh Easy: Simplifying Home Weight Monitoring for Infants N/A
Recruiting NCT04619030 - Augmented Reality (AR): The Future of "Patient Information Leaflets N/A
Recruiting NCT03065686 - Identification of Genetic Factors Implicated in Orofacial Cleft Using Whole Exome Sequencing N/A
Completed NCT02845193 - Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial N/A
Completed NCT03308266 - Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Temporomandibular Disorders N/A
Completed NCT01932164 - Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients N/A
Not yet recruiting NCT06411444 - Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance N/A
Not yet recruiting NCT06292234 - Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla N/A
Recruiting NCT05081258 - Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate N/A
Not yet recruiting NCT04791813 - Assessment of Maxillary Arch Depth and Width in a Group of Surgically Repaired Unilateral Cleft Lip and Palate Children Versus Normal Children .