Tonsillitis
Conditions
Brief summary
Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are several preventive strategies but none of them completely prevent EA. Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might reduce the incidence of postoperative EA.
Interventions
DRUGnormal saline
1\*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.
DRUGropivacaine
1\*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* American Society of anesthesiologist physical status class I/II * tonsillectomy or adenotonsillectomy under general anesthesia
Exclusion criteria
* obstructive sleep apnea * developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission | 1 min after postanesthesia care unit (PACU) admission | PAED score is assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PAED score 10 min after PACU admission | 10 min after postanesthesia care unit (PACU) admission | — |
| PAED score 20 min after PACU admission | 20 min after postanesthesia care unit (PACU) admission | — |
| PAED score 30 min after PACU admission | 30 min after postanesthesia care unit (PACU) admission | — |
| Face legs activity cry consolability (FLACC) score | 1 min after postanesthesia care unit (PACU) admission | FLACC score is assessed. |
| FLACC score 20 min after PACU admission | 20 min after postanesthesia care unit (PACU) admission | — |
| FLACC score 30 min after PACU admission | 30 min after postanesthesia care unit (PACU) admission | — |
| FLACC score 10 min after PACU admission | 10 min after postanesthesia care unit (PACU) admission | — |
Contacts
Primary ContactGo Un Roh, MD
Outcome results
None listed