Pediatric Patients Undergoing Hypospadias SurgeryNCT04836962
Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
A study testing normal saline and dexamethasone in people with Pediatric Patients Undergoing Hypospadias Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. Read more about this study
- Who is it for?
- Ages 6 months to 3 years, men only
- Conditions the study is for
- Pediatric Patients Undergoing Hypospadias Surgery
- What is being tested?
- normal saline and dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 May 2021to 31 Jan 2022
- 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 3 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery
- American Society of Anesthesiologists (ASA) classification 1~2
Who cannot join
- patients who are having uncorrected heart deformity
- patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed
- patients with blood coagulopathy
- patients with diagnosed diabetes
- patients with diagnosed adrenal disease
- patients with fever above 37.5 degrees before surgery
- patients currently taking steroids
- patients contraindicated for dexamethasone administration
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. However, the caudal block is a neuraxial block that has a limitation in its duration with single shot and shows complications and adverse effects. In recent studies, the pudendal nerve block has been suggested as an alternative method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer duration compared to the caudal block, decreased the use of analgesics within 24 hours after surgery, and showed higher parental satisfaction. On the other hand, there have been many studies to prolong the duration of the relatively short duration of caudal block. Among them, dexamethasone administered intravenously is known to improve the duration of various regional blocks and reduce the administration of additional analgesics. The aim of this study is to verify whether a single administration of dexamethasone can enhance the effect of the pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery.
- Being tested
- normal saline, dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
2cc of normal saline is administered to patient instead of dexamethasone.
dexamethasoneDrug
dexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc.
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | normal saline is administrated to patients. Receives: Drug: normal saline |
| dexamethasone | Experimental | 0.5mg/kg dexamethasone is administered to patients. Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration from surgery to first PCA(patient-controlled analgesia) administration
the very first time of PCA usage after surgery, which is automatically recorded in PCA.
Measured: during 48 hours after surgery
Secondary outcomes (4)
the amount of additional analgesia required for postoperative 48hrs.
the amount of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA.
Measured: during 48 hours after surgery
the number of additional analgesia required for postoperative 48hrs.
the number of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA.
Measured: during 48 hours after surgery
pain score for each time period
ask parents about their children's pain score at each time point
Measured: during 48 hours after surgery
overall parents' satisfaction questionnaire
at 48 hours after surgery, parents are asked about satisfaction of their children's pain control
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start7 May 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Patients Undergoing Hypospadias SurgeryStudies 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, Care provider, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeong-Rim Lee, Principal investigator, Department of Anesthesiology and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836962
- Sponsor's protocol ID
- 4-2021-0149
- Status last verified
- Aug 2022
- First submitted
- 6 Apr 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
- ClinicalTrials.gov ID
- NCT04836962
- Acronym / sponsor ID
- 4-2021-0149
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 8 Apr 2021 (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.
Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. However, the caudal block is a neuraxial block that has a limitation in its duration with single shot and shows complications and adverse effects. In recent studies, the pudendal nerve block has been suggested as an alternative method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer duration compared to the caudal block, decreased the use of analgesics within 24 hours after surgery, and showed higher parental satisfaction. On the other hand, there have been many studies to prolong the duration of the relatively short duration of caudal block. Among them, dexamethasone administered intravenously is known to improve the duration of various regional blocks and reduce the administration of additional analgesics. The aim of this study is to verify whether a single administration of dexamethasone can enhance the effect of the pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: normal salinenormal saline is administrated to patients. |
| dexamethasone | Experimental | Drug: dexamethasone0.5mg/kg dexamethasone is administered to patients. |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery
- American Society of Anesthesiologists (ASA) classification 1~2
Key exclusion criteria (8 listed)
- patients who are having uncorrected heart deformity
- patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed
- patients with blood coagulopathy
- patients with diagnosed diabetes
- patients with diagnosed adrenal disease
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 |
|---|---|---|
| normal saline2cc of normal saline is administered to patient instead of dexamethasone. | Drug | control |
| dexamethasonedexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc. | Drug | dexamethasone |
Primary outcome
the duration from surgery to first PCA(patient-controlled analgesia) administration
Time frame: during 48 hours after surgery
the very first time of PCA usage after surgery, which is automatically recorded in PCA.
4 secondary outcomes
the amount of additional analgesia required for postoperative 48hrs.
Time frame: during 48 hours after surgery
the number of additional analgesia required for postoperative 48hrs.
Time frame: during 48 hours after surgery
pain score for each time period
Time frame: during 48 hours after surgery
overall parents' satisfaction questionnaire
Time frame: 48 hours after surgery
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 23 Aug 2022.
- Individual participant dataSharing planned: No
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.
Jeong-Rim Lee principal investigator
Department of Anesthesiology and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal saline and dexamethasone in people with Pediatric Patients Undergoing Hypospadias Surgery, 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 2 inclusion and 8 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 23 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
the duration from surgery to first PCA(patient-controlled analgesia) administration (time frame: during 48 hours after 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 23 Aug 2022.