Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients
Overview
- Phase
- Phase 2
- Intervention
- Intravenous acetaminophen
- Conditions
- Tonsillectomy
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary Endpoint
- Post-operative pain scores
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 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
- •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.
Exclusion Criteria
- •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
Arms & Interventions
IV Tylenol
Participants will receive IV acetaminophen 15mg/kg in the OR.
Intervention: Intravenous acetaminophen
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.
Intervention: Normal saline
Outcomes
Primary Outcomes
Post-operative pain scores
Time Frame: Every 5 minutes after awake in recovery room for 30 minutes
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
Secondary Outcomes
- Quality of emergence from anesthesia(When first spontaneous eye movement occurs in recovery room)