The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test

This study has been completed.
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00853476
First received: February 27, 2009
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

This study aims to compare skin reactivity results between morphine and histamine as a positive control agents in intradermal skin test.


Condition
Intradermal Test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Wheal diameter from morphine skin test at different concentrations compared to standard histamine between 15-30 minutes after skin test [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Histamine hydrochloride and different concentrations of morphine sulfate will be intradermally injected and wheal diameter size will be comparatively measured between 15-30 minutes' time points after the test.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult Healthy Volunteers

Criteria

Inclusion Criteria:

  • age 18-60 years old

Exclusion Criteria:

  • immunodeficiency state
  • cancer
  • severe skin diseases
  • severe medical illnesses
  • malnutrition
  • uncontrolled asthma
  • pregnancy
  • received oral or systemic corticosteroid within 1 month before this study
  • receiving immunosuppressive agents
  • taken antihistamine within 3 days before this study
  • taking beta-blocker
  • previous history of immunotherapy
  • have hypersensitivity reaction to morphine/opiates
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853476

Locations
Thailand
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Jettanong Klaewsongkram, MD Chulalongkorn University
  More Information

Additional Information:
No publications provided

Responsible Party: Jettanong Klaewsongkram, MD, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT00853476     History of Changes
Other Study ID Numbers: Chula-ARC 001/09
Study First Received: February 27, 2009
Last Updated: February 16, 2011
Health Authority: Thailand: Ethical Committee

ClinicalTrials.gov processed this record on April 15, 2014