Tonsillectomy, Adenoidectomy
Conditions
Keywords
Tonsillectomy, Intravenous Acetaminophen, Pediatric
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.
Interventions
Intravenous acetaminophen will be given in the OR.
OTHERNormal saline
Normal saline will given if randomized to this group.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Clinical research coordinator, parent and participant will be masked until participant is discharged from hospital. OR staff will not be masked.
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of emergence from anesthesia | When first spontaneous eye movement occurs in recovery room | 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. |
Outcome results
None listed