IV Acetaminophen and Post-Tonsillectomy Pain

Cincinnati Children's Hospital Medical Center

Status and phase: Withdrawn; Phase 2

Conditions: Adenoidectomy; Tonsillectomy

Treatments: Other: Normal saline; Drug: Intravenous acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT03883893

2018-0565

Details and patient eligibility

About

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.

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

IV Tylenol

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous acetaminophen

Normal Saline

Placebo Comparator group

Description:

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.

Treatment:

Other: Normal saline