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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646592
• Other study ID #: PPI Alfentanil
• Status: Completed
• Phase: N/A
• First received: January 4, 2016
• Last updated: May 2, 2017
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Hôpital Armand Trousseau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Elective surgery under general anesthesia

• Written informed consent

Exclusion Criteria:

• Chronic pain

• Preoperative analgesic drug

• Neurologic disease

• Ophtalmic disease

Related Conditions & MeSH terms

• Anesthesia
• Pain

Intervention

Drug:
• Alfentanil
Bolus of alfentanil 10 µg/kg 5 minutes before skin incision
• sevoflurane or propofol

Locations

Country	Name	City	State
France	Departement d'anesthesie Hopital Armand Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pr Isabelle CONSTANT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change between Pupillary Pain Index before and after alfentanil bolus	pupillometry	Five minutes before incision and just before incision. Each measure = 20 seconds