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Pupil Response in Patients on Opioids. (Pupillometry)

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ClinicalTrials.gov Identifier: NCT02247024
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ulf Kongsgaard, Oslo University Hospital

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.

Condition or disease
Chronic Pain Impaired Pupillary Reflex Opioid-Related Disorders

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.


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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Assessment of Pupillary Reflex in Patients on High-dose Opioids
Study Start Date : January 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : November 2018



Primary Outcome Measures :
  1. Pupillary reflexes [ Time Frame: One year ]
    Dynamic pupillometry


Secondary Outcome Measures :
  1. Opioid and metabolite concentration [ Time Frame: One year ]

Biospecimen Retention:   Samples Without DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer pain on high-dose opioids; i.e. more than 60 morphine equivalents pr day
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247024


Locations
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Norway
Oslo University Hospital, The Norwegian Radium Hospital
Oslo, Norway, 0310
The Norwegian Radium Hospital
Oslo, Norway, 0310
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Ulf E Kongsgaard, MD PhD Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ulf Kongsgaard, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02247024     History of Changes
Other Study ID Numbers: 2014/1226
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: October 2018
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders