Authorised Therapeutic exploratory (Phase II) Sedation in healthy children

The use of intranasal dexmedetomidine for pediatric sedation in non-invasive radiological procedures

EU CTIS ID: 2025-522778-34-00

What this study is testing

Success rate of intranasal dexmedetomidine

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age 6 months - 12 years
  • Weight < 30 kg
  • Indication for non-invasive radiological procedure
  • ASA I or II

You likely can't join if

  • Age < 6 months
  • Acute cerebrovascular conditions
  • ASA III or IV status
  • Hepatic abnormalities
  • Central nervous system dysfunction
  • Spinal cord injuries
See the full eligibility criteria
Who can join
  • Age 6 months - 12 years
  • Weight < 30 kg
  • Indication for non-invasive radiological procedure
  • ASA I or II
What rules you out
  • Age < 6 months
  • Acute cerebrovascular conditions
  • ASA III or IV status
  • Hepatic abnormalities
  • Central nervous system dysfunction
  • Spinal cord injuries
  • Respiratory dysfunction
  • Increased pulmonary artery pressure
  • Renal dysfunction
  • Septic shock
  • Risk of difficult intubation
  • Age > 12 years
  • Hypersensitivity to any of the substances of the product
  • Drug allergy
  • Grade 2 or 3 heart block (unless paced)
  • Taking medicine with rate slowing action on AV-node? For example: digoxin, beta-adrenergic blockers, calcium channel blockers, monoamine oxidase inhibitor or other agents that predispose to bradycardia or hypotension
  • Uncontrolled chronic hypertension/hypotension
  • Congenital cardiac problems
  • Decreased cardiac output

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.