Patients With Cryptorchism Who Are Planning to Undergo OrchiopexyNCT04841018
Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?
A study testing High dose dexamethasone and Low dose dexamethasone in people with Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy, run by Yonsei University at 1 site in South Korea.
Trial summary
Caudal block is one of the most effective modalities to reduce pain both during and after the surgery involving areas under the umbilicus. According to previous research, 0.5mg/kg-1.5mg/kg dexamethasone is known to enhance the analgesic quality of caudal block in children. Read more about this study
- Who is it for?
- Ages 6 months to 6 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy
- What is being tested?
- High dose dexamethasone and Low dose dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Mar 2021to 1 Sep 2023
- 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 6 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages from 6 months old to 6 years old
- Body weight Less than or equal to 16.7kg
- American Society of Anesthesiologists (ASA) classification I or II
- Patients receiving orchiopexy under general anesthesia
Who cannot join
- Patients with uncorrected cardiac anomalies
- Patients with vertebral anomalies
- Diagnosis of diabetes mellitus
- Diagnosis of adrenal disease
- Currently on steroid
- Body temperature above 37.5'C preoperatively
- Allergy to dexamethasone
- Laparoscopic surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Caudal block is one of the most effective modalities to reduce pain both during and after the surgery involving areas under the umbilicus. According to previous research, 0.5mg/kg-1.5mg/kg dexamethasone is known to enhance the analgesic quality of caudal block in children. Despite the fact that this high dose of dexamethasone is used to treat airway edema in actual practice and no adverse side effect related to dosage has been reported, it is 3 to 15 times higher than the daily antiemetic dose of dexamethasone that is used in standard care of anesthesia. Therefore, our study aims to assess the effect of the more practical, antiemetic dose of dexamethasone (0.15mg/kg) as an adjuvant to enhance the quality of caudal block through a non-inferiority trial.
- Being tested
- High dose dexamethasone, Low dose dexamethasone
- Keywords
- caudal block, low dose dexamethasone, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose dexamethasoneDrug
After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.5mg/kg of intravenous dexamethasone
Low dose dexamethasoneDrug
After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.15mg/kg of intravenous dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Higher dose of dexamethasone (0.5mg/kg) that is known to enhance the analgesic quality of caudal block from previous study Receives: Drug: High dose dexamethasone |
| Dexamethasone | Experimental | Lower, antiemetic dose of dexamethasone (0.15mg/kg) Receives: Drug: Low dose dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The need for additional analgesics during the first 48 hrs after surgery
The child's parent is to be educated prior to the surgery so that when the pain score (FLACC or Wong-Baker Faces Scale) is 4 or above at home, he or she receives an additional acetaminophen. The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to assess the need for additional analgesics until 48 hours after the surgery.
Measured: Until 48 hours after the surgery
Secondary outcomes (4)
Time to the first additional analgesic
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
Measured: Until 48 hours after the surgery
total number of additional analgesic
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
Measured: Until 48 hours after the surgery
pain score at each time point
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
Measured: Until 48 hours after the surgery
scale of satisfaction at each time point
The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to find out when the first acetaminophen was given and how many times in total it was given to the child. Also, the pain scores (FLACC, Wong-Baker Faces Scale, Parent Postoperative Pain Measure) and the satisfaction scores were obtained at each time point.
Measured: Until 48 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start24 Mar 2021
- Primary completion29 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Cryptorchism Who Are Planning to Undergo OrchiopexyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients enrolled are allocated into one of the following two groups: control group (group C) who receive a higher dose of dexamethasone known to enhance the effect of caudal block from previous study (0.5mg/kg) and dexamethasone group (group D) who receive a lower, antiemetic dose of dexamethasone (0.15mg/kg)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeong-Rim Lee, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841018
- Sponsor's protocol ID
- 4-2021-0047
- Status last verified
- Sep 2023
- First submitted
- 30 Mar 2021
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy?
- ClinicalTrials.gov ID
- NCT04841018
- Acronym / sponsor ID
- 4-2021-0047
- Keywords
- caudal block, low dose dexamethasone, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 12 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.
Caudal block is one of the most effective modalities to reduce pain both during and after the surgery involving areas under the umbilicus. According to previous research, 0.5mg/kg-1.5mg/kg dexamethasone is known to enhance the analgesic quality of caudal block in children. Despite the fact that this high dose of dexamethasone is used to treat airway edema in actual practice and no adverse side effect related to dosage has been reported, it is 3 to 15 times higher than the daily antiemetic dose of dexamethasone that is used in standard care of anesthesia. Therefore, our study aims to assess the effect of the more practical, antiemetic dose of dexamethasone (0.15mg/kg) as an adjuvant to enhance the quality of caudal block through a non-inferiority trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients enrolled are allocated into one of the following two groups: control group (group C) who receive a higher dose of dexamethasone known to enhance the effect of caudal block from previous study (0.5mg/kg) and dexamethasone group (group D) who receive a lower, antiemetic dose of dexamethasone (0.15mg/kg)
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Drug: High dose dexamethasoneHigher dose of dexamethasone (0.5mg/kg) that is known to enhance the analgesic quality of caudal block from previous study |
| Dexamethasone | Experimental | Drug: Low dose dexamethasoneLower, antiemetic dose of dexamethasone (0.15mg/kg) |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages from 6 months old to 6 years old
- Body weight Less than or equal to 16.7kg
- American Society of Anesthesiologists (ASA) classification I or II
- Patients receiving orchiopexy under general anesthesia
Key exclusion criteria (8 listed)
- Patients with uncorrected cardiac anomalies
- Patients with vertebral anomalies
- Diagnosis of diabetes mellitus
- Diagnosis of adrenal disease
- Currently on steroid
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 |
|---|---|---|
| High dose dexamethasoneAfter caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.5mg/kg of intravenous dexamethasone | Drug | Control |
| Low dose dexamethasoneAfter caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.15mg/kg of intravenous dexamethasone | Drug | Dexamethasone |
Primary outcome
The need for additional analgesics during the first 48 hrs after surgery
Time frame: Until 48 hours after the surgery
The child's parent is to be educated prior to the surgery so that when the pain score (FLACC or Wong-Baker Faces Scale) is 4 or above at home, he or she receives an additional acetaminophen. The outcome assessor calls or text messages the parent at 6 hours, 24 hours, and 48 hours after the surgery to assess the need for additional analgesics until 48 hours after the surgery.
4 secondary outcomes
Time to the first additional analgesic
Time frame: Until 48 hours after the surgery
total number of additional analgesic
Time frame: Until 48 hours after the surgery
pain score at each time point
Time frame: Until 48 hours after the surgery
scale of satisfaction at each time point
Time frame: Until 48 hours after the 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 14 Sep 2023.
- 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
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose dexamethasone and Low dose dexamethasone in people with Patients With Cryptorchism Who Are Planning to Undergo Orchiopexy, 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 4 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 14 Sep 2023. 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?
The need for additional analgesics during the first 48 hrs after surgery (time frame: Until 48 hours after the 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 14 Sep 2023.