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

• Register: ISRCTN
• Last refreshed on: 31 October 2022
• Main ID: ISRCTN15759273
• Date of registration: 08/08/2016
• Prospective Registration: Yes
• Primary sponsor: Uppsala County Council
• Public title: Sedation with dexmedetomidine for insertion of plastic tubes into veins of infants
• Scientific title: Dexmedetomidine sedation for neonatal peripheral vein cannulation
• Date of first enrolment: 01/10/2016
• Target sample size: 66
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN15759273
• Study type: Interventional
• Study design: Double-blind randomised placebo-controlled trial (Treatment)
• Phase: Phase III/IV

Countries of recruitment

Sweden

Contacts

• Name: Mattias Kjellberg

• Name: Peter Frykholm

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 injection (syringe without cannula). The dose is two, one or zero micrograms/kg of dexmedetomidine in group D2, D1 and D0, respectively. The study drug is given 30 minutes before the start of the procedure. A nurse injects the study drug with the syringe directed towards the mucus membrane of the lower cheek when the infant´s head is turned towards one side. The volume of study drug is 0.2 – 0.5 ml. The nurse records if the injection was successful or if the dose may have been swallowed, expunged through vomiting or other reasons. If vomiting occurs within one minute of injection, a second injection of the planned dose is given.

All three groups receive standard care including nursing in a heated humidified environment if indicated, skin contact and cuddling.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

NEODEX1-1

2016-003275-22

Source(s) of Monetary Support

Uppsala County Council

Ethics review

Status:
Approval date:
Contact:

Uppsala IRB, 14/12/2016, ref: Dnr 2016/397

Results

• Results available: Yes
• Date Completed: 01/12/2017