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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.