Congenital Skelectal AnomalyNCT02375191
A Comparative Study of the Effect of Epidural Dexmedetomidine Versus Fentanyl Added to Ropivacaine in Pediatric Orthopedic Surgery
A study testing fentanyl, dexmedetomidine and Ropivacaine in people with Congenital Skelectal Anomaly, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to ropivacaine in pediatric orthopedic surgery Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Congenital Skelectal Anomaly
- What is being tested?
- fentanyl, dexmedetomidine and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Jun 2016
- Phase
- Interventional
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients aged from 3 to 12 years undergoing orthopedic mechanical correction surgery
Who cannot join
- coagulopathy, refusal (parents), current infection on the lumbar area, spinal tract pathology
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to ropivacaine in pediatric orthopedic surgery
- Conditions
- Congenital Skelectal Anomaly
- Being tested
- fentanyl, dexmedetomidine, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
dexmedetomidineDrug
RopivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| fentanyl | Active comparator | 0.2% ropivacaine+ 1 mcg/kg fentanyl Receives: Drug: fentanyl; Drug: Ropivacaine |
| dexmedetomidine | Experimental | 0.2% ropivacaine+1 mcg/kg dexmedetomidine Receives: Drug: dexmedetomidine; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
CHEOPS, FLACC score were measured
Measured: During 48 hrs after pediatric orthopedic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Skelectal AnomalyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375191
- Sponsor's protocol ID
- 4-2014-0921
- Status last verified
- Aug 2016
- First submitted
- 24 Feb 2015
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Effect of Epidural Dexmedetomidine Versus Fentanyl Added to Ropivacaine in Pediatric Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT02375191
- Acronym / sponsor ID
- 4-2014-0921
- Conditions
- Congenital Skelectal Anomaly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Mar 2015 (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.
The purpose of this study is to evaluate the effect of epidural dexmedetomidine added to ropivacaine in pediatric orthopedic surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fentanyl | Active comparator | Drug: fentanyl, Drug: Ropivacaine0.2% ropivacaine+ 1 mcg/kg fentanyl |
| dexmedetomidine | Experimental | Drug: dexmedetomidine, Drug: Ropivacaine0.2% ropivacaine+1 mcg/kg dexmedetomidine |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric patients aged from 3 to 12 years undergoing orthopedic mechanical correction surgery
Key exclusion criteria (1 listed)
- coagulopathy, refusal (parents), current infection on the lumbar area, spinal tract pathology
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 |
|---|---|---|
| fentanyl | Drug | fentanyl |
| dexmedetomidine | Drug | dexmedetomidine |
| Ropivacaine | Drug | dexmedetomidine, fentanyl |
Primary outcome
Postoperative pain score
Time frame: During 48 hrs after pediatric orthopedic surgery
CHEOPS, FLACC score were measured
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 17 Aug 2016.
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?
A study testing fentanyl, dexmedetomidine and Ropivacaine in people with Congenital Skelectal Anomaly, run by Yonsei University 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 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: finished, as of the sponsor's last update on 17 Aug 2016. 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: During 48 hrs after pediatric orthopedic surgery). 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 17 Aug 2016.