IV Acetaminophen in Children Undergoing Palatoplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01760330|
Recruitment Status : Withdrawn (Unable to obtain funding)
First Posted : January 4, 2013
Last Update Posted : March 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cleft Palate||Drug: IV acetaminophen Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Double-Blinded, Randomized Comparison of Intravenous Acetaminophen Versus Placebo in Children Undergoing Palatoplasty|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: IV acetaminophen
IV acetaminophen administered q 4 hrs. for a total of 24 hrs.
Drug: IV acetaminophen
Other Name: Ofirmev
Placebo Comparator: Placebo
Normal saline administered IV every 4 hrs. for a total of 24 hrs.
- Pain [ Time Frame: 24 hrs. post-op. ]Pain scores will be assessed.
- Opioid consumption [ Time Frame: 24 hrs. post-op ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760330
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|