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

Phase 1

• Conditions: Sedation after opioid administrationPharmacokinetic profile after naloxone administered intranasally; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2013-005201-31-SE
• Lead Sponsor: Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-01
• Study Completion: 2017-01-09
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the pharmacokinteic profile in plasma after naloxone administered intranasally in healthy volunteers and pediatric patients<br>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.<br>Degree of sedation after naloxone administration..;Timepoint(s) of evaluation of this end point: For blood sampling 90 minutes after administration of naloxone.<br>Regarding the observation of degree of sedation 1 hour after administration of naloxone/placebo.

Secondary Outcome Measures

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