IV Acetaminophen and Post-Tonsillectomy Pain

NCT03883893 | Withdrawn Phase 2

• 1 other identifier: 2018-0565
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tonsillectomy; Adenoidectomy

Keywords

Tonsillectomy; Intravenous Acetaminophen; Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of emergence from anesthesia

  When first spontaneous eye movement occurs in recovery room

Study Arms (2)

IV Tylenol

ACTIVE COMPARATOR

Participants will receive IV acetaminophen 15mg/kg in the OR.

Drug: Intravenous acetaminophen

Normal Saline

PLACEBO COMPARATOR

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

Interventions

Intravenous acetaminophen DRUG

Intravenous acetaminophen will be given in the OR.

Also known as: IV Tylenol

IV Tylenol

Normal saline OTHER

Normal saline will given if randomized to this group.

Normal Saline

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The subject is age 3 to 10 years (inclusive)
• The subject weighs more than 10.0 kg (inclusive of the tenth kilogram)
• The subject is ASA patient classification I-II
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

MeSH Terms

Interventions

Acetaminophen; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Judy Audas, APRN-CRNA,MSN

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Clinical research coordinator, parent and participant will be masked until participant is discharged from hospital. OR staff will not be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 21, 2019
• Study Start: December 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: April 1, 2023
• Last Updated: April 5, 2022

Record last verified: 2022-03