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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 is a Phase 2 study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 250 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01691690
The ClinicalTrials.gov registry entry for NCT01691690 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Midazolam is the first listed.
NCT01691690 reports 0 study locations.
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.
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