Analgesic Effect of IV Acetaminophen in Tonsillectomies

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).

Conditions

• Adenotonsillitis
• Tonsillitis

Interventions

DRUG

Acetaminophen (paracetamol)

Acetaminophen IV (15 mg/kg).

DRUG

Normal Saline Flush

Saline placebo will be infused intraoperatively.

DRUG

Midazolam

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

DRUG

Sevoflurane

Sevoflurane for anesthesia induction.

DRUG

Nitrous Oxide/Oxygen

Combination of NO2 \& O2 for anesthesia induction.

DRUG

Propofol

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

DRUG

Morphine

Morphine 0.1 mg/kg given prior to intubation.

DRUG

Ondansetron

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

DRUG

Dexamethasone

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

Sponsors & Collaborators

• Nationwide Children's Hospital

  lead OTHER

Principal Investigators

• Arlyne Thung, MD · Nationwide Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

9 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2015-11-30

Completion

2016-07-31

Countries

• United States

Study Locations