Phase 2
N=10
Study on the Effect of a Beta Blocker on Increased Sensitivity to Pain in Humans Caused by Opioids
Hyperalgesia
Bottom Line
View on ClinicalTrials.gov: NCT01222091 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Percent Change From Baseline in Size (Area) of Secondary Hyperalgesia After Cessation of Remifentanil Infusion, a Measure of Opioid-induced Hyperalgesia (OIH). — -28; -34; -19; 141.5 percentage of change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Propranolol (Drug); Placebo to Match Propranolol (Drug); Remifentanil (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Stanford University
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Size (Area) of Secondary Hyperalgesia After Cessation of Remifentanil Infusion, a Measure of Opioid-induced Hyperalgesia (OIH). |
-28; -34; -19; 141.5 | — |
| SECONDARY Objective Opioid Withdrawal Scale (OOWS) |
1.2; 1.1; 1.1; 1.1; 0.1; 0.8 | — |
Summary
This research study explores whether a beta-blocker (propranolol) can prevent a person from becoming more sensitive to pain after administration of an opioid (remifentanil). Beta blockers inhibit the sympathetic (fight or flight) response and are often used to treat angina and high blood pressure. In a previous study in human volunteers, the investigators demonstrated an increased sensitivity to pain after a 60-minute infusion of the opioid remifentanil. The goal of this study is to identify a possible inhibitor of this phenomenon.
Eligibility Criteria
Inclusion Criteria
- Healthy men,
- Age between 18 and 45 years
- Normal weight (according to the table provided by Metropolitan Life Insurance).
Exclusion Criteria
- Hypersensitivity to opioids or naloxone,
- History of addictive disease,
- Significant cardiac, respiratory, gastrointestinal, neurological, dermatological, and psychiatric diseases,
- Concurrent medication with an analgesic drug,
- Student and employees affiliated with our laboratory
Data sourced from ClinicalTrials.gov (NCT01222091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.