Pupil Response in Patients on Opioids.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02247024
• Date of registration: 19/09/2014
• Prospective Registration: Yes
• Primary sponsor: Oslo University Hospital
• Public title: Pupil Response in Patients on Opioids. Pupillometry
• Scientific title: Dynamic Assessment of Pupillary Reflex in Patients on High-dose Opioids
• Date of first enrolment: January 2015
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02247024
• Study type: Observational

Countries of recruitment

Norway

Contacts

• Name: Ulf E Kongsgaard, MD PhD
• Affiliation: Oslo University Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Impaired Pupillary Reflex

Opioid-Related Disorders

Chronic Pain

Primary Outcome(s)

Pupillary reflexes [Time Frame: One year]

Secondary Outcome(s)

Opioid and metabolite concentration [Time Frame: One year]

Secondary ID(s)

2014/1226

Source(s) of Monetary Support

Please refer to primary and secondary sponsors