IV Acetaminophen and Post-Tonsillectomy Pain

Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients

This study is a randomized prospective study to compare the post-operative analgesic efficacy of intravenous acetaminophen 15 mg/kg to an equal volume of 0.9% normal saline when all other analgesic interventions have been standardized for all patients enrolled.

Study Overview

• Status: Withdrawn
• Conditions: Tonsillectomy; Adenoidectomy
• Intervention / Treatment: Drug: Intravenous acetaminophen; Other: Normal saline

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject is age 3 to 10 years (inclusive)
2. The subject weighs more than 10.0 kg (inclusive of the tenth kilogram)
3. The subject is scheduled for the following: Elective tonsillectomy or tonsillectomy with adenoidectomy scheduled on an outpatient basis, with acceptable inclusion of patients also having PETs and/or EUA of ear
4. The subject is ASA patient classification I-II
5. The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.

Exclusion Criteria:

1. Additional surgical procedures are being performed concurrently;
2. The subject is ASA classification > II;
3. The subject has pre-existing allergy or known hypersensitivity to acetaminophen;
4. The subject receives midazolam as a premedication;
5. The subject has a history of chronic malnutrition;
6. The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IV Tylenol; Participants will receive IV acetaminophen 15mg/kg in the OR.	Drug: Intravenous acetaminophen; Intravenous acetaminophen will be given in the OR.; Other Names: IV Tylenol
Placebo Comparator: Normal Saline; Participants will receive 0.9% normal saline in the OR. The amount received will be equivalent of what would be given if they were receiving IV acetaminophen.	Other: Normal saline; Normal saline will given if randomized to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain scores	FLACC (Face, Legs, Activity, Cry, Consolability) behavior scale Each area measured is graded 0 - 2 and then totaled. Total score will range from 0 - 10. A total score of 0 - patient is relaxed and comfortable, 1 - 3 - patient is mildly uncomfortable, 4 - 6 - patient is in moderate pain, 7 - 10 - patient is having severe discomfort/pain	Every 5 minutes after awake in recovery room for 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of emergence from anesthesia	Pediatric Anesthesia Emergence Delirium scale (PAED) This scale uses 5 criteria to determine the extent of emergence delirium in children. "The child makes eye contact with the caregiver", "The child's actions are purposeful", The child is aware of his/her surroundings", The child is restless" and "The child is inconsolable." Each of these 5 catagories are scored on a 0-4 scale. The higher the total number the greater the extent of the emergence delirium.	When first spontaneous eye movement occurs in recovery room

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Judy Audas, APRN-CRNA,MSN, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Pediatric; Tonsillectomy; Intravenous Acetaminophen
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 2018-0565

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No