Anesthesia, EndotrachealNCT03094754
Excision Size and Location on the Postoperative Pain After Nevi Excision in Children
An observational study of Anesthesia, Endotracheal, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The primary purpose of this study is to investigate the effects of excised surface area/body surface area ratio and location of excision on the postoperative pain after nevi excision in children. Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Endotracheal
- What is being tested?
- nevi excision
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Mar 2017to 25 Jan 2018
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children undergoing nevi excision on general anesthesia
Who may be able to join
- children undergoing nevi excision on general anesthesia
Who cannot join
- development disorder
- neurological disorder
- psychological disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon, Seoum, 16499
About this study
Official title: Effect of Excised Surface Area/Body Surface Area Ratio and Location of Excision on the Postoperative Pain After Nevi Excision in Children: Observational Study
The primary purpose of this study is to investigate the effects of excised surface area/body surface area ratio and location of excision on the postoperative pain after nevi excision in children.
The primary purpose of this study is to investigate the effects of excised surface area/body surface area ratio and location of excision on the emergence excitation after nevi excision in children.
- Conditions
- Anesthesia, Endotracheal
- Being tested
- nevi excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nevi excisionProcedure or surgery
After general anesthesia, nevi excision in children is performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
postoperative pain score after nevi excision
Measured: up to 3 hours
Secondary outcomes (1)
emergence agitation score
emergence agitation score after nevi excision
Measured: up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start13 Mar 2017
- Primary completion25 Jan 2018
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, EndotrachealStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Eun Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094754
- Sponsor's protocol ID
- AJIRB-MED-OBS-16-533
- Status last verified
- Dec 2018
- First submitted
- 15 Mar 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Excised Surface Area/Body Surface Area Ratio and Location of Excision on the Postoperative Pain After Nevi Excision in Children: Observational Study
- ClinicalTrials.gov ID
- NCT03094754
- Acronym / sponsor ID
- AJIRB-MED-OBS-16-533
- Conditions
- Anesthesia, Endotracheal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 29 Mar 2017 (actual)
- 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.
The primary purpose of this study is to investigate the effects of excised surface area/body surface area ratio and location of excision on the postoperative pain after nevi excision in children.
The primary purpose of this study is to investigate the effects of excised surface area/body surface area ratio and location of excision on the emergence excitation after nevi excision in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children undergoing nevi excision on general anesthesia
Key inclusion criteria (1 listed)
- children undergoing nevi excision on general anesthesia
Key exclusion criteria (3 listed)
- development disorder
- neurological disorder
- psychological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nevi excisionAfter general anesthesia, nevi excision in children is performed. | Procedure or surgery | – |
Primary outcome
postoperative pain score
Time frame: up to 3 hours
postoperative pain score after nevi excision
1 secondary outcome
emergence agitation score
Time frame: up to 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Endotracheal, run by Ajou University School of Medicine at 1 site in South Korea.
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 3 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: finished, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain score (time frame: up to 3 hours). 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 26 Dec 2018.