Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index

Not Applicable

Completed

• Conditions: Pain; Anesthesia
• Interventions: Drug: Alfentanil; Drug: sevoflurane or propofol

• Registration Number: NCT02646592
• Lead Sponsor: Pr Isabelle CONSTANT

Brief Summary

This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in children under general anesthesia, before skin incision.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Study Start: 2016-04
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Elective surgery under general anesthesia
• Written informed consent

Exclusion Criteria

• Chronic pain
• Preoperative analgesic drug
• Neurologic disease
• Ophtalmic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
alfentanil	sevoflurane or propofol	Children under general anesthesia for elective surgery. Induction with sevoflurane or propofol according to the preference of the patient. Maintenance with sevoflurane. 5 minutes before skin incision, first assessment of the pupillary pain index. Then injection of 10 µg/kg of alfentanil. After 5 minutes second assessment of pupillary pain index. End of study period, beginning of surgery.
alfentanil	Alfentanil	Children under general anesthesia for elective surgery. Induction with sevoflurane or propofol according to the preference of the patient. Maintenance with sevoflurane. 5 minutes before skin incision, first assessment of the pupillary pain index. Then injection of 10 µg/kg of alfentanil. After 5 minutes second assessment of pupillary pain index. End of study period, beginning of surgery.

Primary Outcome Measures

Name	Time	Method
Change between Pupillary Pain Index before and after alfentanil bolus	Five minutes before incision and just before incision. Each measure = 20 seconds	pupillometry

Trial Locations

Locations (1)

Departement d'anesthesie Hopital Armand Trousseau; 🇫🇷 Paris, France