Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Tonsillectomy Clinical Trial

— MODIV-APAP  

Official title:

Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994940
• Other study ID #: 948256
• Status: Completed
• Phase: Phase 4
• Start date: August 28, 2017
• Est. completion date: July 3, 2019

Study information

• Verified date: January 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical patients. The drug is available in an over the counter, inexpensive oral form as well as a considerably more expensive intravenous form. This study will compare opioid requirements and acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus intravenous routes given pre operatively.

Description:

The primary purpose of this study is to compare opioid utilization in post-operative patients undergoing tonsillectomy and adenoidectomy, between IV and PO acetaminophen. Secondarily, it will provide information regarding possible cost savings, pharmacokinetics and safety between these two regimens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 3, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patients ages 3 years to 17 years scheduled for tonsillectomy and adenoidectomy for obstructive sleep apnea with or without additional minor procedures such as sleep endoscopy, unilateral or bilateral myringotomy, insertion of tympanostomy tubes and/or ear exam. ( Minor additional procedures that are frequently combined with tonsillectomy and adenoidectomy but are not commonly considered to have pain that is significantly greater than the tonsillectomy and adenoidectomy).

Exclusion Criteria:

• Patients who meet University of California Davis Children's Hospital (UCDCH) criteria for Pediatric Intensive Care Unit (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 Glucose-6-phosphate dehydrogenase (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

Related Conditions & MeSH terms

• Adenoidectomy
• Tonsillectomy

Intervention

Drug:
• Acetaminophen
already included in arm/group descriptions

Locations

Country	Name	City	State
United States	University of California Davis Children's Hospital	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Dose of Opioid	Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery.	Within 24hrs
Secondary	Proportion of Patients With Severe Pain Score of 7 or Higher	A secondary endpoint is the proportion of patients with pain scores in the severe pain range (7 or higher) on numeric pain rating scale of 0 to 10; higher score more severe.	24 hrs period following surgery
Secondary	Plasma Acetaminophen Level 1 - End of Surgery	mg/L acetaminophen in the plasma at the end of surgery	at the end of surgery, about 1 hour after IV Dose
Secondary	Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration	mg/L acetaminophen in the plasma 3 hours after IV study drug administration	Outcome will be measured 3hrs post first IV Dose