Relation Between Withdrawal Movement for Rocuronium and Emergence Agitation

Inguinal Hernia Clinical Trial

Official title:

Relation Between Withdrawal Movement on Rocuronium Injection and Emergence Agitation and Pain in Preschool Ages: Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02646722
• Other study ID #: AJIRB-MED-OBS-15-169
• Status: Not yet recruiting
• Phase: N/A
• First received: December 28, 2015
• Last updated: January 4, 2016
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: January 2016
• Source: Ajou University School of Medicine
• Contact: Go Un Roh, MD
• Phone: 82-31-219-6435
• Email: gone7968[@]aumc.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Rocuronium results in burning pain on injection site. It can be reduced by local anesthetics or opioid, but still some patients, especially in children, show withdrawal movement for pain. This might resulted from individual pain sensitivity.

Emergence agitation (EA) in children is quite frequent postoperatively and is known to be associated with postoperative pain. If a patient is susceptible to postoperative pain, he or she would have high probability of EA postoperatively. Therefore, the investigators explore the relation of withdrawal movement of rocuronium and EA.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• ASA class I, II

Exclusion Criteria:

• Intravenous cannulation other than a hand or an upper arm with 24 gauge catheter

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia, Inguinal
• Inguinal Hernia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	emergence agitation (Watcha scale)	Watcha scale	1 min after postanesthesia care unit (PACU) admission	No
Secondary	Pain (FLACC scale)	FLACC scale (Face, Leg, Activity, Cry, Consolability)	1. 1 min after postanesthesia care unit (PACU) admission 2. 10 min after PACU admission 3. 20 min after PACU admission 4. 30 min after PACU admission 5. 40 min after PACU admission	No
Secondary	emergence agitation (Watcha scale)		2. 10 min after PACU admission 3. 20 min after PACU admission 4. 30 min after PACU admission 5. 40 min after PACU admission	No