Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Sponsors

Lead Sponsor: University of California, Davis

Source University of California, Davis
Brief 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.

Detailed 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.

Overall Status Completed
Start Date November 11, 2016
Completion Date August 2019
Primary Completion Date July 2019
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Total Dose of Opioid After 24hrs
Secondary Outcome
Measure Time Frame
Pain Score Proportions 24hrs period following surgery
Plasma Acetaminophen level 1 1 hour after IV Dose
Plasma Acetaminophen level 2 Outcome will be measured 3hrs post first IV Dose
Enrollment 80
Condition
Intervention

Intervention Type: Drug

Intervention Name: Acetaminophen

Eligibility

Criteria:

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 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

Gender: All

Minimum Age: 3 Years

Maximum Age: 17 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Cathy Lammers, MD Principal Investigator UC Davis Children's Hospital
Location
Facility: University of California Davis Children's Hospital
Location Countries

United States

Verification Date

October 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Oral Acetaminophen

Type: Experimental

Description: Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision.

Label: Intravenous Acetaminophen

Type: Experimental

Description: Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision.

Acronym MODIV-APAP
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov