UreteroneocystostomyNCT01081535
The Effect of Intravenous (IV) Patient Controlled Analgesic (PCA) With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy
A study testing ketorolac, fentanyl in people with Ureteroneocystostomy, run by Yonsei University.
Trial summary
The effect of IV PCA with ketorolac or fentanyl combined with caudal block for postoperative analgesia in small children undergoing intravesical ureteroneocystostomy. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Ureteroneocystostomy
- What is being tested?
- ketorolac, fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Feb 2010
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients scheduled for elective ureteroneocystostomy were enrolled.
Who cannot join
- History of allergy to aspirin or NSAIDs
- Peptic ulcer disease, and renal function impairment.
- And local infection foci on back, spinal anomalies
- Infectious diseases
- Neurologic disorders
- Seizures and coagulopathies were excluded for sacral epidural block.
About this study
Official title: The Effect of IV PCA With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy
The effect of IV PCA with ketorolac or fentanyl combined with caudal block for postoperative analgesia in small children undergoing intravesical ureteroneocystostomy.
- Conditions
- Ureteroneocystostomy
- Being tested
- ketorolac, fentanyl
- Keywords
- Pediatric patients (6 months-5 years) scheduled elective ureteroneocystostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketorolac, fentanylDrug
intravenous PCA
| Study group | Role | What they receive |
|---|---|---|
| ketorolac | Experimental | Not described Receives: Drug: ketorolac, fentanyl |
| fentanyl | Experimental | Not described Receives: Drug: ketorolac, fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC
Measured: postoperative 24 hours, 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMay 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UreteroneocystostomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Hae Keum Kil, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081535
- Sponsor's protocol ID
- 4-2009-0107
- Status last verified
- Jan 2010
- First submitted
- 4 Mar 2010
- Last updated
- 5 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of IV PCA With Ketorolac or Fentanyl Combined With Caudal Block for Postoperative Analgesia in Small Children Undergoing Intravesical Ureteroneocystostomy
- ClinicalTrials.gov ID
- NCT01081535
- Acronym / sponsor ID
- 4-2009-0107
- Conditions
- Ureteroneocystostomy
- Keywords
- Pediatric patients (6 months-5 years) scheduled elective ureteroneocystostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 Mar 2010 (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 effect of IV PCA with ketorolac or fentanyl combined with caudal block for postoperative analgesia in small children undergoing intravesical ureteroneocystostomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketorolac | Experimental | Drug: ketorolac, fentanyl |
| fentanyl | Experimental | Drug: ketorolac, fentanyl |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients scheduled for elective ureteroneocystostomy were enrolled.
Key exclusion criteria (6 listed)
- History of allergy to aspirin or NSAIDs
- Peptic ulcer disease, and renal function impairment.
- And local infection foci on back, spinal anomalies
- Infectious diseases
- Neurologic disorders
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 |
|---|---|---|
| ketorolac, fentanylintravenous PCA | Drug | fentanyl, ketorolac |
Primary outcome
Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC
Time frame: postoperative 24 hours, 48hours
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 5 Mar 2010.
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.
Hae Keum Kil principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
Questions about this trial
What is this clinical trial studying?
A study testing ketorolac, fentanyl in people with Ureteroneocystostomy, run by Yonsei University.
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 6 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 5 Mar 2010. 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?
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?
Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC (time frame: postoperative 24 hours, 48hours). 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 5 Mar 2010.