Health TrialsbyHealthPanel

Oral Dexmedetomidine in Pediatric MRI

ConditionAnesthesia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-6
SponsorSoroush Merchant

About this trial

The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants 3-6 years old, male and female, all races and ethnicities

Requiring a clinically indicated MRI with general anesthesia

Disqualifiers

Refusal to take oral dexmedetomidine

Known allergy to dexmedetomidine

Inability to take dexmedetomidine at least 90 minutes prior to start of the MRI

Unstable cardiac status including life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction

Trial design

Design model

Sequential

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    Participants will receive oral dexmedetomidine as the sole sedative agent for undergoing MRI

  • General Anesthesia (control group)

    Drug

    Participants will receive general anesthesia for their MRI

Treatment groups

18 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Dexmedetomidine 4 mcg/kgExperimental treatment 1 intervention
Group B: Dexmedetomidine 6 mcg/kgExperimental treatment 1 intervention
Group C: Dexmedetomidine 8 mcg/kgExperimental treatment 1 intervention
Group D: Dexmedetomidine 10 mcg/kgExperimental treatment 1 intervention
Group E: Dexmedetomidine 12 mcg/kgExperimental treatment 1 intervention
Group F: General anesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oral dexmedetomidine dose with adverse event below moderate risk, as designated by SIVA, to obtain adequate MRI study

The primary outcome is determining a dose of oral dexmedetomidine that will safely (adverse event (AE) below moderate risk, as designated by the World Society of Intravenous Anesthesia (SIVA) adverse sedation event reporting tool) provide adequate sedation to successfully complete an MRI. Images should have adequate quality and resolution to be interpretated and will be graded by an attending radiologist. Each MRI sequence will be graded 1-3. 1: no-mild motion artifact; 2: moderate motion artifact; 3: severe motion artifact (non-diagnostic).

Time frame
From date of the first enrollment until the end of assessment of data collected from the last participant, up to 70 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Soroush Merchant

Lead sponsor

Children's Mercy Hospital Kansas City

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: