Pupil Response in Patients on Opioids.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02247024

Acronym

Pupillometry

Enrollment

Registered

2014-09-23

Start date

2015-01-31

Completion date

2018-11-30

Last updated

2019-01-29

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

Conditions

Chronic Pain, Impaired Pupillary Reflex, Opioid-Related Disorders

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* In-patients and out-patients at Oslo University Hospital with cancer pain who have use opioids (morphine, oxycodone, fentanyl or methadone or a combination of these drugs) at least for periods of 4 weeks, and use opioids corresponding to at least 60 mg oral morphine equivalents pr day

Exclusion criteria

* Patients who have undergone eye-surgery that may influence pupillary reflexes * Patients on local medication that may influence pupillary reflexes * Patients with amyloidosis, multiple sclerosis, Horner's syndrome, or ongoing migraine attack * Patients with brain tumor

Design outcomes

Primary

Measure	Time frame	Description
Pupillary reflexes	One year	Dynamic pupillometry

Secondary

Measure	Time frame
Opioid and metabolite concentration	One year

Countries

Norway

Outcome results