Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children

Ajou University School of Medicine

Status: Unknown

Conditions: Tonsillitis

Treatments: Drug: ropivacaine; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02848287

AJIRB-MED-DRU-16-061

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

84 participants in 2 patient groups, including a placebo group

Normal Saline

Placebo Comparator group

Description:

1\*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.

Treatment:

Drug: normal saline

Ropivacaine

Experimental group

Description:

1\*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.

Treatment:

Drug: ropivacaine