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Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures

NCT04897750 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-08-18

No results posted yet for this study

Summary

This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years. The proposed number of study participants by subset is: 8 paediatric participants 1-2 years; 8 paediatric participants \>2-6 years and 9 paediatric participants \>6-17 years.

Conditions

  • Analgesia

Interventions

COMBINATION_PRODUCT

CT001

Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed.

Sponsors & Collaborators

  • Cessatech A/S

    lead INDUSTRY

Principal Investigators

  • Volker Classen, MD · Department of Anaesthesiology, The Juliane Marie Centre Copenhagen University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-19
Primary Completion
2022-05-16
Completion
2022-05-16

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04897750 on ClinicalTrials.gov