Does Hyperbaric Oxygen Therapy Attenuate Secondary Hyperalgesia Areas Induced by a Thermal Injury in Human Volunteers?

Phase 1

• Conditions: Experimental Inflammation; MedDRA version: 17.1Level: PTClassification code 10057480Term: Hyperbaric oxygen therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-003858-14-DK
• Lead Sponsor: Multidisciplinary Pain Center 7612, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-23
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Healthy male volunteers
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Lack of ability to equalize pressure in the inner ear

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of hyperbaric oxygen on experimental inflammation in a blinded study;Secondary Objective: Pain reduction;Primary end point(s): Preconditioning and a reduction in secondary hyperalgesia.;Timepoint(s) of evaluation of this end point: After completing statistical analysis.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain reduction;Timepoint(s) of evaluation of this end point: After completing statistical analysis.