CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 250 enrolled
Drug / intervention
Acetaminophen (paracetamol) +8 moredrug
Likely dose
Acetaminophen (paracetamol) 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01691690
NCT01691690Phase 2Completed

Analgesic Effect of Single Dose Intravenous Acetaminophen in Pediatric Patients Undergoing Tonsillectomy

Nationwide Children's Hospital·interventional·Posted Sep 25, 2012·Updated Apr 6, 2017

In Brief

A Phase 2 clinical trial evaluating Acetaminophen (paracetamol), Normal Saline Flush, and 7 other interventions for Adenotonsillitis and Tonsillitis. Completed, enrolled 250 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 25, 2012
Enrollment StartOct 1, 2012
Primary CompletionNov 1, 2015
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.8 years ago

Interventions

Acetaminophen (paracetamol)drug

Acetaminophen IV (15 mg/kg).

Normal Saline Flushdrug

Saline placebo will be infused intraoperatively.

Midazolamdrug

Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.

Sevofluranedrug

Sevoflurane for anesthesia induction.

Nitrous Oxide/Oxygendrug

Combination of NO2 \& O2 for anesthesia induction.

Propofoldrug

Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.

Morphinedrug

Morphine 0.1 mg/kg given prior to intubation.

Ondansetrondrug

Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.

Dexamethasonedrug

Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis.