Inguinal HerniaNCT02646722
Relation Between Withdrawal Movement for Rocuronium and Emergence Agitation
An observational study of Inguinal Hernia, run by Ajou University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Inguinal Hernia
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: patients scheduled for inguinal hernioplasty in university hospital
Who may be able to join
- ASA class I, II
Who cannot join
- Intravenous cannulation other than a hand or an upper arm with 24 gauge catheter
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Relation Between Withdrawal Movement on Rocuronium Injection and Emergence Agitation and Pain in Preschool Ages: Observational Study
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.
- Conditions
- Inguinal Hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
emergence agitation (Watcha scale)
Watcha scale
Measured: 1 min after postanesthesia care unit (PACU) admission
Secondary outcomes (2)
Pain (FLACC scale)
FLACC scale (Face, Leg, Activity, Cry, Consolability)
Measured: 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)
Measured: 2. 10 min after PACU admission 3. 20 min after PACU admission 4. 30 min after PACU admission 5. 40 min after PACU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Go Un Roh, Ajou University School of Medicine
- Investigators
- Go Un Roh, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646722
- Sponsor's protocol ID
- AJIRB-MED-OBS-15-169
- Status last verified
- Jan 2016
- First submitted
- 28 Dec 2015
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Withdrawal Movement on Rocuronium Injection and Emergence Agitation and Pain in Preschool Ages: Observational Study
- ClinicalTrials.gov ID
- NCT02646722
- Acronym / sponsor ID
- AJIRB-MED-OBS-15-169
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients scheduled for inguinal hernioplasty in university hospital
Key inclusion criteria (1 listed)
- ASA class I, II
Key exclusion criteria (1 listed)
- Intravenous cannulation other than a hand or an upper arm with 24 gauge catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
emergence agitation (Watcha scale)
Time frame: 1 min after postanesthesia care unit (PACU) admission
Watcha scale
2 secondary outcomes
Pain (FLACC scale)
Time frame: 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)
Time frame: 2. 10 min after PACU admission 3. 20 min after PACU admission 4. 30 min after PACU admission 5. 40 min after PACU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Go Un Roh, MD principal investigator
Ajou University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Ajou University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Go Un Roh, MD (82-31-219-6435, gone7968@aumc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emergence agitation (Watcha scale) (time frame: 1 min after postanesthesia care unit (PACU) admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.