Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction (DOLOREAPEDIA)

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Completed

Phase 3

Conditions

Morphine

Intensive Care Units

Child Comfort

Pediatric

Treatments

Drug: Sufentanil

Drug: Alfentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT01235637

DCIC 10 10

Details and patient eligibility

About

The main objective is to assess the efficacy of Alfentanil for pain in children treated by tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the current standard treatment.

Enrollment

40 patients

Sex

All

Ages

1 month to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

child between 1 month and 15 years of age
affiliation to the French social security system or equivalent
child receiving mechanical ventilation for at least 4 hours and less than 48 hours
ventilation to be provided for at least 8 hours
less than 30 days in pediatric intensive care
child under intravenous sedation
consent of both parents
consent of child when possible

Exclusion criteria

curarized child
ketamine treatment
children suffering from facial and/or severe brain traumatism
known hypersensitivity reaction to morphine or intolerance insufficiency to sufentanyl
respiratory
chronic obstructive pulmonary disease
myasthenia
treatment with morphine agonists-antagonists, or combination with MAOIs
renal or liver disorders
preterm birth of more than one month of life (but not at full term by corrected age)
associated treatment or pathology contra-indicating administration of Sufentanyl epidural