IV Acetaminophen and Post-Tonsillectomy Pain

Tonsillectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03883893
• Other study ID #: 2018-0565
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2021
• Est. completion date: April 2023

Study information

• Verified date: March 2022
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoidectomy
• Tonsillectomy

Intervention

Drug:
• Intravenous acetaminophen
Intravenous acetaminophen will be given in the OR.

Other:
• Normal saline
Normal saline will given if randomized to this group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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