A study of uptake and effects of the opioid antidote naloxone given as a nasal spray in children.

Pharmacokinetic and pharmacodynamic aspects in children after intranasal administration of the opioid antagonist naloxone

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000379-96-SE

Enrollment

Unknown

Registered

2017-03-15

Start date

2017-05-05

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetic profile after nasal naloxone administration in Children. In second part study reversal of sedation after opioid use

Interventions

Trade Name: Naloxon Hameln Product Name: Naloxon Hameln Product Code: PRD716892 Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Nas

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy children ASA I&II going through elective surgery/procedures Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergy to naloxone. Person not giving consent. ASA class III&IV

Design outcomes

Primary

Measure	Time frame
Main Objective: Describe pharacokinetics in Children after nasal use of naloxone;Secondary Objective: As second objective study reversal of sedation after opioid use;Primary end point(s): For pharmacokinetic part - analysis of plasma concentration of naloxone. ;Timepoint(s) of evaluation of this end point: For pharmacokinetic part - analysis of plasma concentration of naloxone. Bloddsampling is planned to end 20 minutes after nalas administration.	—

Measure

Time frame

Main Objective: Describe pharacokinetics in Children after nasal use of naloxone;Secondary Objective: As second objective study reversal of sedation after opioid use;Primary end point(s): For pharmacokinetic part - analysis of plasma concentration of naloxone. ;Timepoint(s) of evaluation of this end point: For pharmacokinetic part - analysis of plasma concentration of naloxone. Bloddsampling is planned to end 20 minutes after nalas administration.

—

Secondary

Measure	Time frame
Secondary end point(s): For reversal part - degree of sedation. ;Timepoint(s) of evaluation of this end point: For reversal part - degree of sedation. Naloxone is administered and patient monitored for 60 minutes.	—

Countries

Sweden

Contacts

Public ContactStefan Lundeberg

Pain treatment service, Astrird Lindgren Children's Hospital

stefan.lundeberg@sll.se46851777189

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026