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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2016

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Elective surgery under general anesthesia – Written informed consent Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pr Isabelle CONSTANT
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Pr Isabelle CONSTANT, Professor – Hôpital Armand Trousseau
  • Overall Official(s)
    • Isabelle Constant, PHD, Study Director, University Hospital Armand Trousseau

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