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Clinical Trials/EUCTR2016-003275-22-SE
EUCTR2016-003275-22-SE
Active, not recruiting
Phase 1

Evaluation of the analgesic and sedative effects of dexmedetomidine for neonatal peripheral vein cannulation

ppsala County Council0 sitesOctober 5, 2016
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ConditionsPain on i v cannulationTherapeutic area: Body processes [G] - Physical Phenomena [G01]
DrugsDexdor

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pain on i v cannulation
Sponsor
ppsala County Council
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 5, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ppsala County Council

Eligibility Criteria

Inclusion Criteria

  • •1\. Neonate admitted to neonatal intensive care unit or high dependency unit at Uppsala University Hospital
  • •2\. Planned insertion of a peripheral i v cannula or PICC, when a painful procedure is anticipated due to e g previous difficult i v access
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 66
  • •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

  • •Age \< 33 gestational weeks or \> 44 gestational weeks
  • •Weight \< 1 kg or \> 5 kg
  • •Opioid, alpha\-2\-agonist or anaesthetic given within 12 hours of study start
  • •Planned discharge within 24 hour after intervention

Outcomes

Primary Outcomes

Not specified

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