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Alpha-2 Agonist

Sedatives for Ventilated Pediatric Patients (mini-MENDS Trial)

Phase 3

Recruiting

Led By Heidi Smith, MD, MSCI

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Requiring mechanical ventilation (MV) and sedation

Patients aged 44 weeks post-menstrual age and up to 11 years

Must not have

Benzodiazepine dependency with ongoing medical requirement of continuous benzodiazepine (infusion)

Clinically significant 2nd or 3rd degree heart block or bradycardia < 60 beats per minute

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post icu discharge

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Pivotal Trial

No Placebo-Only Group

Summary

This trial will compare the two most common sedatives used on ventilated pediatric patients to find which one is better.

Who is the study for?

This trial is for children aged from 44 weeks post-menstrual up to 11 years who need a breathing machine and sedation in the ICU at Monroe Carell Jr. Children's Hospital. It excludes those already heavily sedated for over 72 hours, with rapidly resolving respiratory issues, or expected to pass away within a day of joining.

What is being tested?

The study compares two sedatives: Dexmedetomidine (an alpha-2 agonist) and Midazolam (a benzodiazepine), aiming to see which one better reduces delirium and helps with recovery in ventilated pediatric patients.

What are the potential side effects?

Dexmedetomidine may cause low heart rate or blood pressure, nausea, dry mouth; while Midazolam can lead to drowsiness, confusion, headache, and sometimes paradoxical reactions like restlessness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on a breathing machine and under sedation.

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I am between 44 weeks post-menstrual age and 11 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am dependent on benzodiazepines and need them continuously.

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I have a serious heart rhythm problem or my heart beats slower than 60 times a minute.

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I need continuous muscle relaxant infusions for at least 48 hours.

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My weight is over 50 kg.

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I have lost vision in both eyes.

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I have been under continuous sedation for more than 3 days before screening.

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My breathing is quickly getting better, and I am about to stop using the ventilator.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post icu discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post icu discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post icu discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Daily prevalence of delirium

Secondary study objectives

Duration of mechanical ventilation (MV)

Functional status

ICU and hospital lengths of stay

+7 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: DexmedetomidineActive Control1 Intervention

Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of either 4 mcg/mL or 8 mcg/mL dexmedetomidine. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice. Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a "goal" or "target" Richmond Agitation Sedation Score set by the managing clinical team. For patients in the dexmedetomidine group, dose will range from 0.2-2.0 mcg/kg/hr.

Group II: MidazolamActive Control1 Intervention

Route and Concentration. The study drug will be administered intravenously (IV) by continuous infusion at concentrations of either 0.5 mg/mL or 1 mg/mL midazolam. Patients will only receive study drug while in the ICU and on mechanical ventilation, and thus will be monitored with continuous telemetry as per usual ICU practice. Dosing Range. Study drug dose will be titrated in a double-blind manner according to clinical effect to achieve a "goal" or "target" Richmond Agitation Sedation Score set by the managing clinical team. For patients in the midazolam group, dose will range from 0.025-0.25 mg/kg/hr.

0 / 9Eligibility criteria met