IV Acetaminophen and Post-Tonsillectomy Pain

NCT ID: NCT03883893

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2023-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

IV Tylenol

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

Group Type: ACTIVE_COMPARATOR

Intravenous acetaminophen

Intervention Type: DRUG

Intravenous acetaminophen will be given in the OR.

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: OTHER

Normal saline will given if randomized to this group.

Interventions

Intravenous acetaminophen

Intravenous acetaminophen will be given in the OR.

Intervention Type: DRUG

Normal saline

Normal saline will given if randomized to this group.

Intervention Type: OTHER

Other Intervention Names

IV Tylenol

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judy Audas, APRN-CRNA,MSN

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Other Identifiers

2018-0565

Identifier Type: -

Identifier Source: org_study_id