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

• Sponsor: Pr Isabelle CONSTANT (Other)
• Overall Status: Completed
• CT.gov ID: NCT02646592
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Actual Duration (Months): 8
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Anesthesia	Drug: Alfentanil; Drug: sevoflurane or propofol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

1. Change between Pupillary Pain Index before and after alfentanil bolus [Five minutes before incision and just before incision. Each measure = 20 seconds]

   pupillometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective surgery under general anesthesia

• Written informed consent

Exclusion Criteria:

• Chronic pain

• Preoperative analgesic drug

• Neurologic disease

• Ophtalmic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Departement d'anesthesie Hopital Armand Trousseau	Paris		France	75012

Sponsors and Collaborators

• Pr Isabelle CONSTANT

Investigators

• Study Director: Isabelle Constant, PHD, University Hospital Armand Trousseau

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pr Isabelle CONSTANT, Professor, Hôpital Armand Trousseau
• ClinicalTrials.gov Identifier: NCT02646592
• Other Study ID Numbers: PPI Alfentanil
• First Posted: Jan 5, 2016
• Last Update Posted: May 3, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Alfentanil; Propofol; Sevoflurane

Study Results

No Results Posted as of May 3, 2017