Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01691690 · ClinicalTrials.gov registry record · Phase 2
Analgesic Effect of IV Acetaminophen in Tonsillectomies
A Phase 2 study, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT01691690: Completed Phase 2 study, sponsored by Nationwide Children's Hospital.
NCT01691690 is a Phase 2 study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 250 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01691690, a Phase 2 study, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study Summary
Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).
Primary Outcome
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. 5 pain measurements were performed at 0, 5, 15, 30, and 60 minutes after PACU arrival. This is the number of participants who reached a FLACC score \>/= 4 at one or more time points.
Interventions
- DRUG Midazolam
- DRUG Sevoflurane
- DRUG Acetaminophen (paracetamol)
- DRUG Normal Saline Flush
- DRUG Nitrous Oxide/Oxygen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
What the finished NCT01691690 record still lists
NCT01691690 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 5 interventions - of which Midazolam is the first listed.
NCT01691690 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01691690 about?
NCT01691690 is a clinical study titled "Analgesic Effect of IV Acetaminophen in Tonsillectomies". Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as comp...
What is the current status of trial NCT01691690?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2012-10. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01691690?
The interventions under investigation include: Midazolam (DRUG), Sevoflurane (DRUG), Acetaminophen (paracetamol) (DRUG), Normal Saline Flush (DRUG), Nitrous Oxide/Oxygen (DRUG).
Who is sponsoring clinical trial NCT01691690?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01691690's enrollment target sits among peer trials
250 222nd of 2000 higher than 1,768 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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
- NCT00483249 · 250 participants · NA
Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
- NCT00777712 · 250 participants
Mechanisms Underlying Impaired Diabetic Wound Healing
- NCT01451502 · 250 participants · NA
Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
- NCT01771718 · 250 participants
Pilot Study on In-vivo Non-invasive Skin Imaging Using Multiphoton Microscopy
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