NCT02646722

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

December 28, 2015

Last Update Submit

January 4, 2016

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • emergence agitation (Watcha scale)

    Watcha scale

    1 min after postanesthesia care unit (PACU) admission

Secondary Outcomes (2)

  • Pain (FLACC scale)

    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

  • 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

Study Arms (4)

No pain

patients show no pain on rocuronium injection

mild pain

patients move a hand only on rocuronium injection

moderate pain

patients move a arm on rocuronium injection

severe pain

patients show generalized movement because of pain

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

patients scheduled for inguinal hernioplasty in university hospital

You may qualify if:

  • ASA class I, II

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Go Un Roh, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Go Un Roh, MD

CONTACT

82-31-219-6435gone7968@aumc.ac.kr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 6, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 6, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share