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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02646592
Enrollment
14
Registered
2016-01-05
Start date
2016-04-30
Completion date
2016-12-31
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Pain

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.

Interventions

DRUGAlfentanil

Bolus of alfentanil 10 µg/kg 5 minutes before skin incision

Sponsors

Pr Isabelle CONSTANT
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Elective surgery under general anesthesia * Written informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change between Pupillary Pain Index before and after alfentanil bolusFive minutes before incision and just before incision. Each measure = 20 secondspupillometry

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026