IV Acetaminophen in Children Undergoing Palatoplasty

Status Withdrawn

Clinical Trial Summary

This project is being used to assess the utility of intravenous acetaminophen in the pediatric population undergoing palate repairs. This study is a prospective randomized double blinded placebo controlled study. The investigators will have two arms, one group of patients will receive intravenous acetaminophen and one group that will receive a placebo at a total of four doses over 24 hours. The results of this study may affect the intraoperative anesthetic management as well as post-operative surgical management of this specific patient population. The goal is to determine the benefit of adding a non-opioid analgesic and hypothesizing that it may reduce the amount of narcotic consumption in the post anesthesia care unit as well as during the post-operative stay.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Cleft Palate

Clinical Trial Details

NCT number	NCT01760330
Study type	Interventional
Source	Nationwide Children's Hospital
Contact
Status	Withdrawn
Phase	Phase 2
Start date	December 2015
Completion date	December 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00340977` - Svangerskap, Arv, Og Miljo (Pregnancy, Heredity and Environment)
Completed	`NCT05166408` - Fistiulation Rate Following Primary Cleft Repair≤	N/A
Recruiting	`NCT03839290` - Development of the Palate in Bilateral Orofacial Cleft Newborns One Year After Early Neonatal Cheiloplasty
Recruiting	`NCT01867632` - Acellular Dermal Matrix in Primary Furlow Palatoplasty	N/A
Completed	`NCT02900014` - Validation of a Production Method of Stem Cell Isolated From the Nasal Cavity for an Innovative Cell Therapy of Cleft Palate	N/A
Withdrawn	`NCT02953145` - The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery	Phase 4
Completed	`NCT04725370` - Characterization of Cleft Lip and Palate Conditions in Guatemala
Withdrawn	`NCT03572907` - Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate : Aesthetic and Functional Impact.
Enrolling by invitation	`NCT02702869` - Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)
Completed	`NCT02583100` - Improving Outcomes in Cleft Palate Surgery	N/A
Recruiting	`NCT06072495` - Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI	N/A
Completed	`NCT04718558` - Optic Nerve Sheath Diameter Measurement in Cleft Palate Repair
Not yet recruiting	`NCT05357092` - Effects of AlignBabyCleft (ABaCleft)	N/A
Completed	`NCT01500109` - Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair	N/A
Completed	`NCT01252264` - FaceBase Biorepository
Completed	`NCT00397917` - Oral Cleft Prevention Program	Phase 3
Enrolling by invitation	`NCT03632044` - Evaluation of Trigeminal Nerve Blockade	Phase 4
Completed	`NCT04277273` - Characteristics of a Maxillofacial Prosthesis Consultation Within Assistance Publique - Hopitaux de Paris	N/A
Completed	`NCT05405738` - Cleft Palate Technique and Maxillary Growth
Completed	`NCT03170505` - Using of Acellular Dermal Matrix in Cleft Palatal Fistula and Compare With Use of Conchal Cartolage	N/A