Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Cleft Palate, sponsored by Loma Linda University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measure of the study will be to measure opioid (Fentanyl and Morphine) consumption during the intraoperative period first postoperative 24 hours (measured in 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 |
What the finished NCT01500109 record still lists
NCT01500109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 669-participant average among 9 other Cleft Palate trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cleft Palate
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01500109's enrollment target sits among peer trials
45 8th of 9 higher than 2 of 9 other Cleft Palate trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cleft Palate trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
QL vs LAI for Palatoplasty
RECRUITING · NA
-
Targeting Surgeons' Decision-Making for Cleft Lip Surgery
ACTIVE NOT RECRUITING · NA
-
Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery
RECRUITING · Phase 4
-
Evaluation of Trigeminal Nerve Blockade
ACTIVE NOT RECRUITING · Phase 4
-
Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials
COMPLETED
-
Sleep and Behavior in Children With Cleft Palate
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia