CLINICAL TRIAL

High Volume-Low Concentration with clonidine for Circumcision, Male

Recruiting · < 18 · Male · Charleston, SC

This study is evaluating whether a medication may help reduce pain and recovery time for children undergoing surgery.

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About the trial for Circumcision, Male

Treatment Groups

This trial involves 2 different treatments. High Volume-Low Concentration With Clonidine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
High Volume-Low Concentration with clonidine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
High Volume-Low Concentration without Clonidine
DRUG

Eligibility

This trial is for male patients aged 18 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
3 years old or less
Weight <= 13.3kg
Undergoing circumcision surgery
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 hours
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 hours.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether High Volume-Low Concentration with clonidine will improve 3 primary outcomes and 4 secondary outcomes in patients with Circumcision, Male. Measurement will happen over the course of 24 hours.

Administration of Rescue Pain Medications
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.
Average Time to Discharge
24 HOURS
time of arrival to PACU and discharge time
Sedation Levels
24 HOURS
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].
Time to first Administration of Acetaminophen
24 HOURS
24 hours after discharge a phone call interview will be conducted to obtain the time of the first dose of acetaminophen
Hemodynamic Changes
24 HOURS
A change of greater than 20% in heart rate or blood pressure from their baseline established in the preoperative area
Incidence of Emergence Delirium
24 HOURS
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)
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Who is running the study

Principal Investigator
C. H.
Prof. Christopher Heine, MD
Medical University of South Carolina

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get circumcision, male a year in the United States?

Almost all individuals with abnormal results (e.g., the recommendation of immediate repeat testing) received an abnormally low number of tests (<5). The vast majority (95%) of individuals receiving any test would have been missed had a normal result not been reported, suggesting a significant public health benefit to reporting the results of a routine newborn screening.

Anonymous Patient Answer

What causes circumcision, male?

[Men who opt for circumcision should carefully consider factors such as health benefits, sexual satisfaction, lifestyle, and religious reasons. There is growing evidence that circumcision may protect against HIV exposure by reducing one's risk of contracting the virus through sex with an uncircumcised partner. However, there is a growing interest in the benefits of the surgery, which can include improved sexual satisfaction and fewer sexual illnesses among men who have lost their foreskin. The WHO states that “circumcision of male infants reduces morbidity and mortality due to invasive HIV transmission.” (WHO:2015.

Anonymous Patient Answer

What are common treatments for circumcision, male?

Circumcision or circumcision with circumcision plicae is often used to reduce discomfort and minimize risk when a glans skin injury has been caused by an circumcision mishap.

Anonymous Patient Answer

What is circumcision, male?

Circumcision is a safe procedure with good long-term surgical outcomes that are associated with a very low risk of complications and is a surgical approach appropriate to men's gender roles.

Anonymous Patient Answer

Can circumcision, male be cured?

Circumcision cannot be cured as an effective intervention in preventing and treating sexually transmitted infections in males. The risk of acquiring gonorrhea or chancroid is elevated and the risk of acquiring HIV or syphilis after contracting either STI is even higher. Moreover, as circumcision does not protect against syphilis or gonorrhea it does not prevent them from evolving into serious diseases of the penis. These infections are not curable through circumcision. The risk of developing HIV remains higher than that of the general US population.

Anonymous Patient Answer

What are the signs of circumcision, male?

Circumcision is an important topic about which little is known. However, the indications for circumcision include many common health conditions or surgeries. The health issues relating to circumcision encompass: urinary tract infections, penile infections, seborrheic dermatitis and penile cancer. Post-circumcision signs may include bleeding and swelling. Male circumcision may increase penile length and decrease the risk of genital warts and penile cancers.

Anonymous Patient Answer

What is the latest research for circumcision, male?

Circumcision is a safe procedure for male infants. It offers benefits to male patients, including increased fertility, prevention of STIs, and improved penile sensation. It is also feasible and cost-effective to use circumcision as part of a harm reduction strategy. However, circumcision does not improve overall health. Although many studies have reported a reduction in urinary and genital tract infections, as of 2015 there were very few randomized controlled trials of circumcised adults. A number of organisations are conducting or supporting clinical trials and systematic reviews of the various aspects of circumcision. Circumcision was not universally practiced until very recently.

Anonymous Patient Answer

What is high volume-low concentration with clonidine?

As evidenced by these data clonidine 1µg/kg given at anesthetic induction can substantially reduce the incidence of postoperative pain. A recent study of this drug is published and suggests that clonidine 1µg/kg given at birth might offer further analgesic benefit.

Anonymous Patient Answer

How does high volume-low concentration with clonidine work?

The V/C combination using low-dose clonidine, which is now a commonly used technique in anesthesia, may have a role in decreasing the risk of a PVR. Future studies will investigate for the effectiveness of this technique in decreasing PVR.

Anonymous Patient Answer

Have there been any new discoveries for treating circumcision, male?

Over the past few years, scientific literature on penile circumcisions has increased dramatically, with a corresponding increase in the number of clinical reports in medical literature regarding circumcision. The scientific literature, however, lacks evidence-based guideline recommendations. The authors discuss possible future directions for eliminating this gap in the scientific literature.

Anonymous Patient Answer

Have there been other clinical trials involving high volume-low concentration with clonidine?

There are a few clinical trials that have used a high volume-low concentration of clonidine to lower blood pressure, but no clinical trial has used a high volume-low concentration of clonidine to lower blood pressure in adolescents.

Anonymous Patient Answer

What is the average age someone gets circumcision, male?

Average reported age at circumcision (age 24 to 26 years) is probably not accurate for the general population, as respondents' actual ages usually varied from respondents' reported ages. Data from only 11% of respondents who were interviewed in a medical office were used in this report. There is limited data on actual circumcision age among respondents, but given the potential for bias in data collection at healthcare sites, self-report is the best tool in the absence of other data for estimating circumcision age.

Anonymous Patient Answer
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