IV Acetaminophen and Post-Tonsillectomy Pain

Phase 2

Withdrawn

• Conditions: Adenoidectomy; Tonsillectomy
• Interventions: Drug: Intravenous acetaminophen; Other: Normal saline

• Registration Number: NCT03883893
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Study Start: 2021-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-04-05
• Primary Completion: 2022-10
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Tylenol	Intravenous acetaminophen	Participants will receive IV acetaminophen 15mg/kg in the OR.
Normal Saline	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.

Primary Outcome Measures

Name	Time	Method
Post-operative pain scores	Every 5 minutes after awake in recovery room for 30 minutes	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

Secondary Outcome Measures

Name	Time	Method
Quality of emergence from anesthesia	When first spontaneous eye movement occurs in recovery room	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.