IV Acetaminophen and Post-Tonsillectomy Pain

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Treatments: Acetaminophen

Criteria

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