Male CircumcisionEarly Phase 1NCT04263064
High Volume Caudal Study
A Early Phase 1 study testing High Volume-Low Concentration without Clonidine and High Volume-Low Concentration with clonidine in people with Male Circumcision, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The primary objective is to evaluate the effect of clonidine on the duration of analgesia provided by a high volume-low concentration caudal block for pediatric aurgical procedres. In addition, caudal clonidine's effect on length of recovery and post-operative emergence agitation will be measured. Read more about this study
- Who is it for?
- Ages 0 to 3 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision
- What is being tested?
- High Volume-Low Concentration without Clonidine and High Volume-Low Concentration with clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2020to 19 Aug 2022
- Phase
- Early Phase 1
- 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 0 to 3 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 3 years old or less
- Weight <= 13.3kg
- American Society of Anesthesiology Physical Status (ASA) 1 or 2
- Undergoing circumcision surgery
- Patients whose plan of care includes caudal block
Who cannot join
- Known allergy to clonidine, epinephrine, or amide local anesthetics
- Inability or unwillingness of parent or legal guardian to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Effect of Clonidine on High Volume-Low Concentration Caudals
The primary objective is to evaluate the effect of clonidine on the duration of analgesia provided by a high volume-low concentration caudal block for pediatric aurgical procedres. In addition, caudal clonidine's effect on length of recovery and post-operative emergence agitation will be measured.
- Conditions
- Male Circumcision
- Being tested
- High Volume-Low Concentration without Clonidine, High Volume-Low Concentration with clonidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Volume-Low Concentration without ClonidineDrug
The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine) caudal block
High Volume-Low Concentration with clonidineDrug
The study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine).
| Study group | Role | What they receive |
|---|---|---|
| High Volume-Low Concentration without Clonidine | Active comparator | The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine). Receives: Drug: High Volume-Low Concentration without Clonidine |
| High Volume-Low Concentration with clonidine | Experimental | The study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine). Receives: Drug: High Volume-Low Concentration with clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Pain
The effect of clonidine on the duration of the analgesia provided by a high volume-low concentration caudal will be measured in the Post Anesthesia Care Unit pain assessments using CHEOPS score every at 0, 30, 60, and 90 minutes after arrival to PACU.
The CHEOPS pain score tool is an observational scale for measuring postoperative pain in children aged 1-7 yrs. The tool includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain).
Measured: 24 hours
Administration of Rescue Pain Medications
Data will be collected and analyzed on the need for rescue pain medications by collecting doses of opioids administered the Post Anesthesia Care Unit.
Measured: 24 hours
Time to first Administration of Acetaminophen
24 hours after discharge a phone call interview will be conducted to obtain the time of the first dose of acetaminophen
Measured: 24 hours
Secondary outcomes (4)
Hemodynamic Changes
A change of greater than 20% in heart rate or blood pressure from their baseline established in the preoperative area
Measured: 24 hours
Incidence of Emergence Delirium
The incidence of emergence delirium will be collected utilizing the PAED Scale at 0, 30, 60, and 90 minutes after arrival to the Post Anesthesia Care Unit. The PAED scale will measure the presence of delirium by scoring behaviors from 1-4 (1=calm, 2=not calm but consolable, 3=moderately agitate, restless or not easily calmed, 4=combative, excited, thrashing around)
Measured: 24 hours
Sedation Levels
Measured in PACU utilizing Ramsay Sedation Scale at 0, 30, 60, and 90 minutes after arrival in PACU. The Ramsay sedation scale is a scoring of responses (1-6) [1=anxious or restless, 2=cooperative, oriented, tranquil, 3=responding to commands, 4=brisk response to stimulus, 5=sluggish response to stimulus, 6=no response to stimulus].
Measured: 24 hours
Average Time to Discharge
time of arrival to PACU and discharge time
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start6 Mar 2020
- Primary completion17 Aug 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male CircumcisionStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, observer blinded study will attempt to determine if there is any benefit to the addition of clonidine to a HVLC caudal block, both in duration of analgesia and occurrence of emergence agitation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Heine, MD, Medical University of South Carolina
- Investigators
- Christopher Heine, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263064
- Sponsor's protocol ID
- Pro00091670
- Status last verified
- Mar 2023
- First submitted
- 1 Feb 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clonidine on High Volume-Low Concentration Caudals
- ClinicalTrials.gov ID
- NCT04263064
- Acronym / sponsor ID
- Pro00091670
- Conditions
- Male Circumcision
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 10 Feb 2020 (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.
The primary objective is to evaluate the effect of clonidine on the duration of analgesia provided by a high volume-low concentration caudal block for pediatric aurgical procedres. In addition, caudal clonidine's effect on length of recovery and post-operative emergence agitation will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, observer blinded study will attempt to determine if there is any benefit to the addition of clonidine to a HVLC caudal block, both in duration of analgesia and occurrence of emergence agitation.
| Arm | Type | Receives |
|---|---|---|
| High Volume-Low Concentration without Clonidine | Active comparator | Drug: High Volume-Low Concentration without ClonidineThe control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine). |
| High Volume-Low Concentration with clonidine | Experimental | Drug: High Volume-Low Concentration with clonidineThe study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine). |
Who may qualify
- Ages
- 0 to 3 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 3 years old or less
- Weight <= 13.3kg
- American Society of Anesthesiology Physical Status (ASA) 1 or 2
- Undergoing circumcision surgery
- Patients whose plan of care includes caudal block
Key exclusion criteria (2 listed)
- Known allergy to clonidine, epinephrine, or amide local anesthetics
- Inability or unwillingness of parent or legal guardian to give informed consent
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 Volume-Low Concentration without ClonidineThe control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine) caudal block | Drug | High Volume-Low Concentration without Clonidine |
| High Volume-Low Concentration with clonidineThe study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine). | Drug | High Volume-Low Concentration with clonidine |
Primary outcome
Presence of Pain
Time frame: 24 hours
The effect of clonidine on the duration of the analgesia provided by a high volume-low concentration caudal will be measured in the Post Anesthesia Care Unit pain assessments using CHEOPS score every at 0, 30, 60, and 90 minutes after arrival to PACU. The CHEOPS pain score tool is an observational scale for measuring postoperative pain in children aged 1-7 yrs. The tool includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain).
Administration of Rescue Pain Medications
Time frame: 24 hours
Data will be collected and analyzed on the need for rescue pain medications by collecting doses of opioids administered the Post Anesthesia Care Unit.
Time to first Administration of Acetaminophen
Time frame: 24 hours
24 hours after discharge a phone call interview will be conducted to obtain the time of the first dose of acetaminophen
4 secondary outcomes
Hemodynamic Changes
Time frame: 24 hours
Incidence of Emergence Delirium
Time frame: 24 hours
Sedation Levels
Time frame: 24 hours
Average Time to Discharge
Time frame: 24 hours
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 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Male Circumcision
Active, not recruiting
A Study Comparing The Effect Of Local Application Of Polyfax Versus Coconut Oil On Outcome Of Plastibell Circumcision In A Tertiary Care Hospital
Circumcision, Male
Recruiting
The Effect of Health Riddles on Fear, Anxiety, and Pain in Circumcised Children
Circumcision, Male
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.
Christopher Heine, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing High Volume-Low Concentration without Clonidine and High Volume-Low Concentration with clonidine in people with Male Circumcision, run by Medical University of South Carolina at 1 site in United States.
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 5 inclusion and 2 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 Mar 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Presence of Pain (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 Mar 2023; AzTrials last refreshed its copy on 30 Oct 2026.