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Dexmedetomidine for Pediatric Anesthesia
Study Summary
This trial is testing whether lower doses of the drug Dexmedetomidine can achieve the same effect as a higher dose of the drug, when used in combination with Sevoflurane, in children aged 1-3 years old.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have an abnormality in my airway.I have irregular heartbeats.I have a gastrointestinal condition.I have a metabolic condition like diabetes.I have lung or chest wall disease but haven't had symptoms worsen in the last 2 weeks.I have liver problems.I was born with a heart condition.I have a condition affecting my brain such as developmental delay, cerebral palsy, or seizures.I or my family have a history of malignant hyperthermia.My baby was born before 37 weeks of pregnancy.I have kidney problems.I am between 1 month and 3 years old and need surgery.I have an imbalance in my body's electrolytes.My BMI is above the 95th percentile for my age.I am taking medication that could affect anesthesia.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- Group 1: Dexmedetomidine 0.5 mcg/kg 1-6 months
- Group 2: Dexmedetomidine 1 mcg/kg 6-12 months
- Group 3: Dexmedetomidine 1 mcg/kg 1-3 years
- Group 4: Placebo 1-6 months
- Group 5: Dexmedetomidine 0.5 mcg/kg 6-12 months
- Group 6: Dexmedetomidine 1 mcg/kg 1-6 months
- Group 7: Dexmedetomidine 0.5 mcg/kg 1-3 years
- Group 8: Placebo 6-12 months
- Group 9: Placebo 1-3 years
Frequently Asked Questions
Could you provide a list of recent trials assessing the efficacy of Dexmedetomidine 0.5 mcg/kg over 1-6 months?
"Currently, 110 clinical trials encompassing Dexmedetomidine 0.5 mcg/kg 1-6 months are underway with 23 of those in the third phase. While mainly based out of Karachi, Sindh, 207 medical centres globally have research for this medication ongoing."
Are there any age restrictions for recruitment in this clinical trial?
"This research is open to all participants between 1 and 36 months of age."
Does my medical profile qualify me to take part in the experiment?
"Requirements for entry into this clinical trial are anesthesia, pediatric age range between 1 month and 36 months. Approximately 180 individuals must be recruited to participate in the experiment."
What is the standard use of Dexmedetomidine 0.5 mcg/kg 1-6 months?
"Dexmedetomidine 0.5 mcg/kg 1-6 months is a widely used therapy to treat this disease as well as additional ailments such as ventilations, mechanical, cyclic vomiting syndrome and intubations."
To what extent is enrollment in this clinical trial being pursued?
"Correct. According to the information hosted on clinicaltrials.gov, this trial is presently seeking participants and was first posted on February 18th 2018. To complete this study, 180 patients need to be enrolled from a single medical centre."
Are there any vacancies currently available for participants of this clinical trial?
"Affirmative. Clinicaltrials.gov has records of this clinical trial beginning its recruitment process on February 18th 2018 and was last updated March 29th 2022, with the aim to recruit 180 patients from one location."
What potential risks does Dexmedetomidine 0.5 mcg/kg 1-6 months pose to individuals?
"The safety rating of Dexmedetomidine 0.5 mcg/kg 1-6 months was determined to be 3, since this is a Phase 4 trial and the associated medication has been approved."
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