Study comparing one dose pre-surgery Acetaminophen (Tylenol) pills to one dose IV Acetaminophen for pain control

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"Does Acetaminophen (Tylenol) given before surgery, lessen need for opioids/narcotics?"
Age:
4 to 17 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
tonsillectomy, adenoidectomy
Type:
Drug study, Phase 4
Investigator:
Description
The purpose of the study is to compare pain control between two forms of acetaminophen, and to possibly save money for future patients who have to undergo the same surgery as your child.

Acetaminophen, otherwise known as Tylenol or Ofirmev, has been used by medical providers to help treat moderate to severe surgical pain in children. It is used with various medications including opioids or narcotics to treat pain after surgery. Opioids/narcotics are strong morphine-like medicines that can have multiple side effects that can be very serious in children after tonsillectomies and adenoidectomies (for example: slower breathing rates, sedation, and obstruction).

Because of this, there is interest in the use of acetaminophen to manage surgical pain. Other studies have shown that if acetaminophen is given to a child, then the child will need less of these stronger pain medications to be comfortable after surgery. Acetaminophen comes in various forms including an inexpensive oral form (Tylenol) and a more expensive intravenous (IV) form (Ofirmev).

We think that one loading oral dose of acetaminophen given before surgery can provide better pain control (as measured by less need for morphine-like medicine) compared to one dose of intravenous acetaminophen for pediatric tonsillectomy and adenoidectomy patients
This study requires
Acetaminophen study dose administration
Two blood draws through IV (one while under anesthesia)
Who can participate?
Inclusion Criteria:

- Patients ages 4 years to 17 years scheduled for tonsillectomy and adenoidectomy for obstructive sleep apnea.


Exclusion Criteria:

- Patients having additional procedures or surgical interventions

- Patients who meet UCDCH criteria for PICU admission: on home oxygen pre-operatively, exhibit airway obstruction when awake (stertor above larynx, stridor at larynx), sleep study with apnea hypoxia index greater than 25 or sleep oxygen saturation nadir <80%, cardiac disease, difficult intubation.

- Patients with a known allergy to acetaminophen

- Patients with known hepatic insufficiency or severe hepatic disease

- Patients with known G6PD deficiency

- Patients who are malnourished (ie lower levels of glutathione)

- Patients with severe renal impairment as defined by calculated creatinine clearance <20 ml/min (per modified Schwarz equation)

- Patients who are pregnant
Resources
Schedule
Study duration and period
1 hour before surgery and continuing for approximately 24 hours after surgery
Recruitment period
From Nov. 3, 2016
Location
UC Davis Children's Hospital
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Tonsillectomy
  • Adenoidectomy

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