Interest of Using the Sevoflurane in the Prevention of Newborns Pain

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00420693

Enrollment

Registered

2007-01-11

Start date

2006-08-31

Completion date

Unknown

Last updated

2009-01-15

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

Conditions

Newborn, Pain Measurement

Brief summary

The objective of this randomized and controlled study is to compare the sedation with sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate peripheral inserted central catheter insertion in a pediatric and neonatal intensive care. Main measurements concern success or failure of insertion, duration of procedure, movements of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate, respiratory frequency and oxygen saturation.

Interventions

DRUGsevoflurane

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Infants born between the 28th and 41th weeks of gestation admitted in intensive care unit * Patient requiring a mechanical ventilation or CPAP * Patient requiring a KTEC * Given consent

Exclusion criteria

* Contraindication to sévoflurane * Patient already sedated with morphin and/or hypnotics * Patient presenting neurologic troubles * Patient enrolled in other study\* * Infant without legacy representant

Design outcomes

Primary

Measure	Time frame
Lasted realization of the gesture defined by delay between the first draining and the end of the bandage	24 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026