EUCTR2013-005201-31-SE
Active, not recruiting
Phase 1
Pharmacokinetic profile and pharmacodynamic effects after intranasal naloxone administration in volunteers and pediatric patients. - Intranasal naloxone
Karolinska University Hospital0 sites20 target enrollmentAugust 1, 2014
ConditionsSedation after opioid administrationPharmacokinetic profile after naloxone administered intranasallyTherapeutic area: Body processes [G] - Physical Phenomena [G01]
DrugsNaloxon Hameln
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Sedation after opioid administrationPharmacokinetic profile after naloxone administered intranasally
- Sponsor
- Karolinska University Hospital
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •Allergy to nalxone. Parents/children not giving consent.
- •Children less than 6 months and older than 10 years
Outcomes
Primary Outcomes
Not specified
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