N/A N=22 Randomized Triple-blind Basic Science

Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil

Hyperalgesia

Bottom Line

View on ClinicalTrials.gov: NCT00991809 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2013

Primary outcome: Primary: Pain Tolerance — 105.3; 19.2 seconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Alfentanil (Drug); Diphenhydramine (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Johns Hopkins University
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Tolerance	105.3; 19.2	—
SECONDARY Pain Threshold	20.7; 8.6	—

Summary

The purpose of this study was to follow a person's response to experimental pain after multiple consecutive exposures to alfentanil or diphenhydramine to see if the person can tolerate the pain more, less, or the same at the end of the study.

Eligibility Criteria

Inclusion Criteria

Age 18-55
No active medical conditions
BMI between 20-30
Able and willing to perform/tolerate pain procedures
Able to communicate in English

Exclusion Criteria

Lifetime substance use disorder, except for alcohol abuse/dependence in remission
Use of opiates in last 3 months
Ongoing marijuana use
Acute or chronic pain
Neurologic or psychiatric condition known to influence cold pressor testing (peripheral neuropathy, major depression, or schizophrenia)
Current use of prescribed or over the counter pain medications
Previous adverse reaction to opiate medications or diphenhydramine
Use of tobacco or caffeine on study days

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00991809). 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.