Metabolism and effects of naloxone given as a spray in healthy volunteers and children.

Pharmacokinetic profile and pharmacodynamic effects after intranasal naloxone administration in volunteers and pediatric patients. - Intranasal naloxone

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005201-31-SE

Enrollment

Registered

2014-08-01

Start date

2015-03-31

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Sedation after opioid administration Pharmacokinetic profile after naloxone administered intranasally

Interventions

Trade Name: Naloxon Hameln Product Name: Naloxon Hameln Product Code: PRD716892 Pharmaceutical Form: Injection INN or Proposed INN: naloxone Other descriptive name: NALOXONE HYDROCHLORIDE Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In the pharmacokinetic study we are to examine adult healthy volunteers as a first step. In the second phase childen undergoing elective surgery/anesthesia will be given naloxone intranasally and blood sampling will be collected during the peroperative phase. Children, ASA class I and II, age 6 months to 10 years will be included. For the observation part of the study children undergoing painful procedures requiring opioid treatment Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Allergy to nalxone. Parents/children not giving consent. Children less than 6 months and older than 10 years

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the pharmacokinteic profile in plasma after naloxone administered intranasally in healthy volunteers and pediatric patients Study the effect on sedation of oipioid after administration of the antidote naloxone;Secondary Objective: Side effects of intranasal application of naloxone. ;Primary end point(s): Plasma concentration of naloxone. Degree of sedation after naloxone administration..;Timepoint(s) of evaluation of this end point: For blood sampling 90 minutes after administration of naloxone. Regarding the observation of degree of sedation 1 hour after administration of naloxone/placebo.	—

Measure

Time frame

Main Objective: To study the pharmacokinteic profile in plasma after naloxone administered intranasally in healthy volunteers and pediatric patients Study the effect on sedation of oipioid after administration of the antidote naloxone;Secondary Objective: Side effects of intranasal application of naloxone. ;Primary end point(s): Plasma concentration of naloxone. Degree of sedation after naloxone administration..;Timepoint(s) of evaluation of this end point: For blood sampling 90 minutes after administration of naloxone. Regarding the observation of degree of sedation 1 hour after administration of naloxone/placebo.

—

Secondary

Measure	Time frame
Secondary end point(s): Degree of discomfort of nasal administration;Timepoint(s) of evaluation of this end point: 60 minutes after application of naloxone	—

Countries

Sweden

Contacts

Public ContactStefan Lundeberg

Pain Tretament Service, Astrid Lindgren Children's Hospital

stefan.lundeberg@karolinska.se+46851777271

Outcome results

None listed

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