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

Dexmedetomidine sedation for neonatal peripheral vein cannulation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15759273

Enrollment

Registered

2016-08-08

Start date

2016-10-01

Completion date

Unknown

Last updated

2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural pain (from i v cannulation) in neonatal intensive care Neonatal Diseases

Interventions

Neonates planned for i v cannulation are randomised (computerised randomisation procedure) to receive two, one or zero micrograms/kg of dexmedetomidine. The study drug will be administered by buccal i

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Age 44 weeks gestational age 2. Weight 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Skin conductance 2. regional cerebral tissue oxygen saturation (rcSaO2) using near-infrared spectroscopy (NIRS) 3. Hemodynamics (non-invasive blood pressure via automatic cuff pressure) 4. Heart rate measured with EKG 5. Peripheral capillary oxygen saturation (SpO2) using a saturation probe 6. Breath rate, assessed via a EKG monitor and observation by nurse 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. EKG, SpO2 and breath rate monitoring will continue for 24 hours. 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.	—

Measure

Time frame

1. Skin conductance 2. regional cerebral tissue oxygen saturation (rcSaO2) using near-infrared spectroscopy (NIRS) 3. Hemodynamics (non-invasive blood pressure via automatic cuff pressure) 4. Heart rate measured with EKG 5. Peripheral capillary oxygen saturation (SpO2) using a saturation probe 6. Breath rate, assessed via a EKG monitor and observation by nurse 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. EKG, SpO2 and breath rate monitoring will continue for 24 hours. 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.

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Countries

Sweden

Contacts

Public ContactMattias Kjellberg

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026