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

Phase 3

Completed

• Conditions: Procedural pain (from i v cannulation) in neonatal intensive care; Neonatal Diseases

• Registration Number: ISRCTN15759273
• Lead Sponsor: ppsala County Council

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34309839/ (added 19/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-08
• Study Completion: 2017-12-01
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Neonate admitted to neonatal intensive care unit or high dependency unit at Uppsala University Hospital
2. Discharge to ward planned after more than 24 hours
3. 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
4. Gestational age range: 33 - 44 weeks
5. Weight range: 1 - 5 kg

Exclusion Criteria

1. Age<33 weeks or > 44 weeks gestational age
2. Weight < 1 kg or > 5 kg
3. Patients that have received general anaesthesia, alpha-2-agonists or opioid analgesia within 12 hours preceding the start of the protocol
4. Signs of cardiac failure
5. Signs of respiratory failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Observational pain scale (N-PASS). 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
<br> 1. Skin conductance<br> 2. regional cerebral tissue oxygen saturation (rcSaO2) using near-infrared spectroscopy (NIRS)<br> 3. Hemodynamics (non-invasive blood pressure via automatic cuff pressure)<br> 4. Heart rate measured with EKG<br> 5. Peripheral capillary oxygen saturation (SpO2) using a saturation probe<br> 6. Breath rate, assessed via a EKG monitor and observation by nurse<br><br> All the above secondary outcome (except for breath rate observation) measures will be recorded continuously from when the study drug is administered until one hour after the end of the procedure.<br> EKG, SpO2 and breath rate monitoring will continue for 24 hours.<br><br> Plasma concentration of study drug is also a secondary outcome measure. A total of three plasma samples during 24 hours will be analysed with population based pharmacokinetic methods.<br>