NCT02955732: PINDEX

Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients

Completed Phase 4 Last updated 12 September 2018

What this trial tests

Phase 4 trial testing Dexmedetomidine in Procedural Sedation in 50 participants. Completed in 10 September 2018.

Timeline

1 January 2017

Primary endpoint
30 April 2017

10 September 2018

Quick facts

Lead sponsor	Turku University Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 January 2017
Primary completion	30 April 2017
Estimated completion	10 September 2018
Sites	1 location across Finland

Drugs / interventions tested

• Dexmedetomidine (dexmedetomidine) — full drug profile →

Conditions studied

• Procedural Sedation — all drugs for Procedural Sedation →

Sponsor

Turku University Hospital

Who can join

Adults 1 Month to 12, any sex, with Procedural Sedation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

We aim to characterize the bioavailability and pharmacokinetics of dexmedetomidine after intranasal dosing employing pharmacometrics methods in otherwise healthy 1 month to 11 years of age children scheduled for minor surgery or other procedures requiring sedation or anesthesia.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. New idea to promote the clinical applications of stem cells or their extracellular vesicles in central nervous system disorders: Combining with intranasal delivery.
   Li Y, Wu H, Jiang X, Dong Y, et al · · 2022 · cited 28× · PMID 35967290 · DOI 10.1016/j.apsb.2022.04.001