Sedation with dexmedetomidine for insertion of plastic tubes into veins of infants

Phase 1

Conditions: Pain on i v cannulation
Therapeutic area: Body processes [G] - Physical Phenomena [G01]

Registration Number: EUCTR2016-003275-22-SE

Lead Sponsor: ppsala County Council

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim is to determine if buccal dexmedetomidine reduces the pain reaction associated with peripheral vein cannulation in neonates. ;Secondary Objective: The secondary aim is to evaluate the safety of buccal admininstration of dexmedetomidine in neonates and obtain premininary pharmacokinetic data on. ;Primary end point(s): Significant difference in pain score assessment (N-PASS) between the groups;Timepoint(s) of evaluation of this end point: Assessment will be performed 5 minutes before the start of the procedure, at the time of the first attempt of vein cannulation and at every subsequent attempt as applicable, and five minutes after the end of the procedure.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Skin conductance and NIRS: as for primary endpoint.<br>Blood pressure, heart rate, saturation and breath rate: continuously for 12 hours after intervention;Secondary end point(s): Change in skin conduction<br>Change in blood pressure > 20% from baseline<br>Bradycardia – heart rate < 100 bpm<br>Hypoventilation leading to SpO2 < 90%<br>