Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

NCT02994940 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 948256
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillectomy; Adenoidectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of Patients With Severe Pain Score of 7 or Higher

  24 hrs period following surgery

• Plasma Acetaminophen Level 1 - End of Surgery

  at the end of surgery, about 1 hour after IV Dose

• Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration

  Outcome will be measured 3hrs post first IV Dose

Study Arms (2)

Oral Acetaminophen

EXPERIMENTAL

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.

Drug: Acetaminophen

Intravenous Acetaminophen

EXPERIMENTAL

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.

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

already included in arm/group descriptions

Also known as: OFIRMEV

Intravenous Acetaminophen; Oral Acetaminophen

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Children's Hospital

Sacramento, California, 95817, United States

Location

Related Publications (1)

• Lammers CR, Schwinghammer AJ, Hall B, Kriss RS, Aizenberg DA, Funamura JL, Senders CW, Nittur V, Applegate RL 2nd. Comparison of Oral Loading Dose to Intravenous Acetaminophen in Children for Analgesia After Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Dec 1;133(6):1568-1576. doi: 10.1213/ANE.0000000000005678.

  PMID: 34304234 DERIVED

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Richard L. Applegate II MD
• Organization: UC Davis Anesthesiology & Pain Medicine

rapplegate@ucdavis.edu

916-734-5028

Study Officials

• Cathy Lammers, MD

  UC Davis Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 16, 2016
• Study Start: August 28, 2017
• Primary Completion: July 3, 2019
• Study Completion: July 3, 2019
• Last Updated: February 18, 2021
• Results First Posted: December 9, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)