NCT02247024

Pupil Response in Patients on Opioids.

Dynamic Assessment of Pupillary Reflex in Patients on High-dose Opioids

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of pupillary reflex in patients on high-dose opioids. Clinical assessment of pain intensity, sedation score, and other side effects of opioids. Measurements of the concentration of opioids and their active metabolites in blood.

Detailed description

Pupil size reflects the balance between sympathetic and parasympathetic systems. Pupil size and reaction are also influenced by drugs, where opioids result in miosis, an effect that is not considered to be influenced by opioid tolerance. However, cancer patients on high-dose opioids do not always present small pupil size. We want to perform a dynamic assessment of pupillary reflex in patients on high-dose opioids. In addition to pupil size measurements under standard room light conditions, two pupil size reflexes will by assessed: the pupillary light reflex when the pupil is exposed to light, and the reflex dilation during a standardized noxious stimulus. On the same time we will assess pain intensity, sedation score, and other side effects of opioids while measuring the concentration of opioids and their active metabolites in blood. In addition we will register all concomitant medication that also might influence pupil size and reaction. Patients on more than 60 morphine equivalents pr day will be included.

Conditions

• Chronic Pain
• Impaired Pupillary Reflex
• Opioid-Related Disorders

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-08-01
• Completion: 2018-11-01
• First posted: 2014-09-23
• Last updated: 2019-01-29

Locations

2 sites across 1 country: Norway