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NCT01500109 · ClinicalTrials.gov registry record · NA
Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair
A NA study of Cleft Palate, sponsored by Loma Linda University.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT01500109 is a NA study of Cleft Palate that has completed, run by Loma Linda University. The registered enrollment target is 45 participants, below the 669-participant average among 9 other Cleft Palate trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01500109, a NA study of Cleft Palate, has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects. Additionally, the investigators will determine if patients who receive acetaminophen have less opioid related side-effects. The study will have three study groups based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine) alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the intraoperative period and 24 hours after surgery for all patients within the study and converted to morphine equivalents.
Conditions Studied
Interventions
- DRUG Oral acetaminophen
- DRUG Ofirmev®
- DRUG Opioid only
Study Locations (1)
California
- Loma Linda University - Loma Linda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01500109
The ClinicalTrials.gov registry entry for NCT01500109 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 669-participant average among 9 other Cleft Palate trials with a reported enrollment target (93% lower). The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cleft Palate appearing as the primary indexed condition, and to 3 interventions - of which Oral acetaminophen is the first listed.
NCT01500109 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01500109 about?
NCT01500109 is a clinical study titled "Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair". The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects. Additionally, the investigators will determine if patients who receive acetaminophen have less opioid...
What is the current status of trial NCT01500109?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2011-11. Estimated completion is 2014-08.
What conditions does trial NCT01500109 study?
This clinical trial studies the following conditions: Cleft Palate.
What interventions are being tested in trial NCT01500109?
The interventions under investigation include: Oral acetaminophen (DRUG), Ofirmev® (DRUG), Opioid only (DRUG).
Who is sponsoring clinical trial NCT01500109?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01500109 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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