Chronic PainPupillometryNCT02247024
Pupil Response in Patients on Opioids.
An observational study of Chronic Pain and Impaired Pupillary Reflex, run by Oslo University Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Impaired Pupillary Reflex, Opioid-Related Disorders
- How many people
- 63 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2015to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer pain on high-dose opioids; i.e. more than 60 morphine equivalents pr day
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo University Hospital, The Norwegian Radium Hospital
Oslo, 0310
The Norwegian Radium Hospital
Oslo, 0310
About this study
Official title: Dynamic Assessment of Pupillary Reflex in Patients on High-dose 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.
Read the 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.
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillary reflexes
Dynamic pupillometry
Measured: One year
Secondary outcomes (1)
Opioid and metabolite concentration
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulf Kongsgaard, Oslo University Hospital
- Investigators
- Ulf E Kongsgaard, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247024
- Sponsor's protocol ID
- 2014/1226
- Acronym
- Pupillometry
- Status last verified
- Oct 2018
- First submitted
- 19 Sep 2014
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kongsgaard UE, Hoiseth G. Dynamic assessment of the pupillary reflex in patients on high-dose opioids. Scand J Pain. 2019 Jul 26;19(3):465-471. doi: 10.1515/sjpain-2019-0032.
PubMed 31031265
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Assessment of Pupillary Reflex in Patients on High-dose Opioids
- ClinicalTrials.gov ID
- NCT02247024
- Acronym / sponsor ID
- Pupillometry / 2014/1226
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer pain on high-dose opioids; i.e. more than 60 morphine equivalents pr day
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pupillary reflexes
Time frame: One year
Dynamic pupillometry
1 secondary outcome
Opioid and metabolite concentration
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Derived from this study: PubMed 31031265Kongsgaard UE, Hoiseth G. Dynamic assessment of the pupillary reflex in patients on high-dose opioids. Scand J Pain. 2019 Jul 26;19(3):465-471. doi: 10.1515/sjpain-2019-0032.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf E Kongsgaard, MD PhD principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Impaired Pupillary Reflex, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupillary reflexes (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02247024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019; AzTrials last refreshed its copy on 1 Nov 2026.