Overview

Analgesic Effect of IV Acetaminophen in Tonsillectomies

Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nationwide Children's Hospital
Treatments:
Acetaminophen
Analgesics
Dexamethasone
Hydromorphone
Midazolam
Morphine
Nitrous Oxide
Ondansetron
Propofol
Sevoflurane
Criteria
Inclusion Criteria:

1. Male or female patients aged 2 years and younger than 9 years old requiring
postoperative admission for tonsillectomy or adenotonsillectomy.

2. Functional status as assigned by the American Society of Anesthesiology (ASA)
classification of I (1), II (2) or III (3).

3. Have a parent/guardian who are able to provide written informed consent in accordance
with Human Investigations Committee/Institutional Review Board (HIC/IRB) regulations.

4. Have parent/guardian who are compliant with routine medical care, capable of
subjective evaluation and able to read, understand and sign the informed consent.

Exclusion Criteria:

1. Male or female patients age greater than 9 years.

2. Have an American Society of Anesthesiologists Physical Status > IV (4)(severe disease
that is life threatening).

3. Have a known hypersensitivity or allergy to acetaminophen.

4. Have a known allergy or intolerance to morphine or fentanyl.

5. Have received chronic opioid analgesic therapy prior to surgery.

6. Have renal disease.

7. Have hepatic disease.

8. Are morbidly obese (% BMI > 95).