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Completed

NCT Number: NCT02247024

Pupil Response in Patients on Opioids.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pupillary reflexes

    Time frame: One year

    Dynamic pupillometry

Secondary outcomes

  1. Opioid and metabolite concentration

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Acronym: Pupillometry

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 23, 2014
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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