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Dose-Response of Adenosine for Perioperative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00298636
Recruitment Status : Completed
First Posted : March 2, 2006
Last Update Posted : August 2, 2006
Information provided by:
Xsira Pharmaceuticals

Brief Summary:
Adenosine A1 and A2 receptors are widely distributed in the brain and spinal cord and represent a non-opiate target for pain management. Activated spinal A1 receptors inhibit sensory transmission by inhibiting the slow ventral root potential, which is the C-fiber-evoked excitatory response associated with nociception. Adenosine may inhibit intrinsic neurons through an increase in K+ conductance and presynaptic inhibition of sensory nerve terminals to inhibit the release of substance P and perhaps glutamate. Although adenosine A3 receptors are not found in the nervous system, adenosine is also known to have anti-inflammatory properties that may contribute to pain relief in the peripheral setting of inflammation.

Condition or disease Intervention/treatment Phase
Perioperative Pain Drug: adenosine Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Escalating Dose-Response Trial of Intravenous Adenosine for Perioperative Analgesia in Females Undergoing Abdominal Hysterectomy or Myomectomy
Study Start Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Primary Outcome Measures :
  1. Dose-response

Secondary Outcome Measures :
  1. efficacy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female gender; age 18 to 65 years;
  • American Society of Anesthesiology (ASA) physical classification I to III;
  • scheduled for non-emergent abdominal hysterectomy (with or without salpingo-oophorectomy) or myomectomy under general anesthesia;

Exclusion Criteria:

  • ASA physical classification of IV or V;
  • documented history of cardiovascular disease including coronary artery disease, uncontrolled hypertension, aortic stenosis, congestive heart failure, cardiac arrhythmias or conduction defects greater that first degree atrioventricular (AV) block, sinoatrial (SA) or AV node disease including sick sinus syndrome or symptomatic bradycardia, presence of devices including pacemakers or internal defibrillators, or history of symptoms consistent with any of the aforementioned conditions (e.g., angina, dyspnea on exertion, paroxysmal nocturnal dyspnea);
  • history of asthma, bronchospastic lung disease, or hyper-reactive airway disease;
  • history of gout;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00298636

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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Miami/Miller School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University/Forsyth Medical Center
Winston Salem, North Carolina, United States, 27157
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Memorial Hermann-Memorial City Hospital
Houston, Texas, United States, 77024
Sponsors and Collaborators
Xsira Pharmaceuticals
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Principal Investigator: Tong J Gan, M.D. Duke University
Layout table for additonal information Identifier: NCT00298636    
Other Study ID Numbers: ADO-122
First Posted: March 2, 2006    Key Record Dates
Last Update Posted: August 2, 2006
Last Verified: August 2006
Additional relevant MeSH terms:
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Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action