CryptorchidismNCT01604915
Comparison of Dexamethasone Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia in Children Undergoing Orchiopexy
A study testing Caudal block in people with Cryptorchidism, run by Yonsei University at 1 site in South Korea.
Trial summary
Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures. However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves. Read more about this study
- Who is it for?
- Ages 6 months to 5 years, men only
- Conditions the study is for
- Cryptorchidism
- What is being tested?
- Caudal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Feb 2013
- 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
- Men only
- No healthy volunteers
- Child
Who may be able to join
- ASA status I-II
- Children aged 6 months to 5 years
- Undergoing day-case unilateral orchiopexy
Who cannot join
- Hypersensitivity to any local anesthetics
- Bleeding diathesis
- Infections at puncture sites
- Preexisting neurological disease
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Effect of Dexamethasone Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Orchiopexy
Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures.
However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves.
Read more
In order to decrease postoperative analgesic requirements after caudal block, various drugs such as opioids, ketamine, clonidine, or dexmedetomidine to local anesthetics has been investigated. However, their use has been limited by adverse effects in children.
Recently, many study suggested that epidurally administered dexamethasone could reduce the incidence and severity of postoperative pain in adults. But there is no study concerning the use of dexamethasone, as an adjuvant agent for the caudal epidural block in children.
The investigators performed prospective randomized double-blind study to examine the analgesic effect of dexamethasone added to ropivacaine and ropivacaine alone in caudal analgesia on postoperative pain control in pediatric patients undergoing orchiopexy.
80 children (aged 0.5-5 yr) undergoing day-case orchiopexy were included in this prospective, randomized, double-blinded study. After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R , dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR. Postoperative pain was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be followed for the duration of hospital stay, an expected average of 3 hours.
After discharge, rescue analgesic consumption, pain scores, and adverse effects were evaluated for 24h.
The time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation. Twenty-four hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview.
- Conditions
- Cryptorchidism
- Being tested
- Caudal block
- Medical subject headings
- Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal blockProcedure or surgery
After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R.
Caudal blockProcedure or surgery
After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR.
| Study group | Role | What they receive |
|---|---|---|
| Group R | Placebo comparator | Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered. Receives: Procedure: Caudal block |
| Group DR | Experimental | Dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR. Receives: Procedure: Caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic rescue medication
The time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation. Twenty-four hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview.
Measured: from the end of surgery to the first registration of a VAS(0-10) ≥ 5 by parent's observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CryptorchidismStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Rim LEE, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604915
- Sponsor's protocol ID
- 4-2012-0149
- Status last verified
- Jul 2013
- First submitted
- 18 May 2012
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khafagy HF, Refaat AI, El-Sabae HH, Youssif MA. Efficacy of epidural dexamethasone versus fentanyl on postoperative analgesia. J Anesth. 2010 Aug;24(4):531-6. doi: 10.1007/s00540-010-0949-7. Epub 2010 May 14.
PubMed 20467878Kim EM, Lee JR, Koo BN, Im YJ, Oh HJ, Lee JH. Analgesic efficacy of caudal dexamethasone combined with ropivacaine in children undergoing orchiopexy. Br J Anaesth. 2014 May;112(5):885-91. doi: 10.1093/bja/aet484. Epub 2014 Feb 2.
PubMed 24491414
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Effect of Dexamethasone Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Orchiopexy
- ClinicalTrials.gov ID
- NCT01604915
- Acronym / sponsor ID
- 4-2012-0149
- Conditions
- Cryptorchidism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 May 2012 (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.
Single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures.
However, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves.
In order to decrease postoperative analgesic requirements after caudal block, various drugs such as opioids, ketamine, clonidine, or dexmedetomidine to local anesthetics has been investigated. However, their use has been limited by adverse effects in children.
Recently, many study suggested that epidurally administered dexamethasone could reduce the incidence and severity of postoperative pain in adults. But there is no study concerning the use of dexamethasone, as an adjuvant agent for the caudal epidural block in children.
The investigators performed prospective randomized double-blind study to examine the analgesic effect of dexamethasone added to ropivacaine and ropivacaine alone in caudal analgesia on postoperative pain control in pediatric patients undergoing orchiopexy.
80 children (aged 0.5-5 yr) undergoing day-case orchiopexy were included in this prospective, randomized, double-blinded study. After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R , dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR. Postoperative pain was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be followed for the duration of hospital stay, an expected average of 3 hours.
After discharge, rescue analgesic consumption, pain scores, and adverse effects were evaluated for 24h.
The time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation. Twenty-four hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R | Placebo comparator | Procedure: Caudal blockNormal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered. |
| Group DR | Experimental | Procedure: Caudal blockDexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA status I-II
- Children aged 6 months to 5 years
- Undergoing day-case unilateral orchiopexy
Key exclusion criteria (5 listed)
- Hypersensitivity to any local anesthetics
- Bleeding diathesis
- Infections at puncture sites
- Preexisting neurological disease
- Diabetes mellitus
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 |
|---|---|---|
| Caudal blockAfter inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R. | Procedure or surgery | Group R |
| Caudal blockAfter inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR. | Procedure or surgery | Group DR |
Primary outcome
Time to first analgesic rescue medication
Time frame: from the end of surgery to the first registration of a VAS(0-10) ≥ 5 by parent's observation
The time to first supplemental oral analgesic medication demand was defined as the time from the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation. Twenty-four hours after surgery, reports of delayed side effects and demands for rescue analgesics from the child were gathered from parents via a telephone interview.
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 9 Jul 2013.
- Background: PubMed 20467878Khafagy HF, Refaat AI, El-Sabae HH, Youssif MA. Efficacy of epidural dexamethasone versus fentanyl on postoperative analgesia. J Anesth. 2010 Aug;24(4):531-6. doi: 10.1007/s00540-010-0949-7. Epub 2010 May 14.
- Derived from this study: PubMed 24491414Kim EM, Lee JR, Koo BN, Im YJ, Oh HJ, Lee JH. Analgesic efficacy of caudal dexamethasone combined with ropivacaine in children undergoing orchiopexy. Br J Anaesth. 2014 May;112(5):885-91. doi: 10.1093/bja/aet484. Epub 2014 Feb 2.
Related trials for Cryptorchidism
Active, not recruitingObservational study
INVESTIGATION OF THE GENETIC ETIOLOGY OF HERNIA SAC DEVELOPMENT IN MALE CHILDREN WITH UNDESCENDED TESTIS AND INGUINAL HERNIA
Indirect Inguinal Hernia, Undescended Testis
Recruiting
Orchidopexy Randomized Clinical Assessment
Unilateral Cryptorchidism
Recruiting
Transection Versus Ligation of Internal Spermatic Vessels in Laparoscopic Fowler-Stephens Orchidopexy
Cryptorchidism
Recruiting
Comparison of Single Incision Scrotal vs Standard Two Incision Inguinal Orchidopexy in Children Under 10 Years.
Undescended Testis
RecruitingObservational study
Role of the Environment and Endocrine Disruptors in Child Cryptorchidism
Cryptorchidism
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 Caudal block in people with Cryptorchidism, 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 3 inclusion and 5 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 9 Jul 2013. 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?
Time to first analgesic rescue medication (time frame: from the end of surgery to the first registration of a VAS(0-10) ≥ 5 by parent's observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01604915, which also lists 2 linked publications.
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 9 Jul 2013.