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Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01952626
First Posted: September 30, 2013
Last Update Posted: April 9, 2015
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.
Information provided by (Responsible Party):
Younghoon Jeon, Kyungpook National University
  Purpose
Intrathecal administration of morphine is often used for control of postoperative pain. However, pruritus is one of the most common side effects of intrathecal morphine . Specific serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.

Condition Intervention
Morphine Adverse Reaction Drug: Ondansetron Drug: Palonosetron

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron

Resource links provided by NLM:


Further study details as provided by Younghoon Jeon, Kyungpook National University:

Primary Outcome Measures:
  • Incidence of pruritus [ Time Frame: 24 hours after spinal anesthesia ]
    record of the incidence of pruritus after spinal anesthsia


Enrollment: 80
Study Start Date: April 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ondansetron
Intravenous administration of ondansetron 4mg 15 minutes before spinal anesthesia
Drug: Ondansetron
intravenous injection
Other Name: zofran
Experimental: palonosetron
Intravenous administration of palonosetron 0.075mg 15 minutes before spinal anesthesia
Drug: Palonosetron
intravenous injection
Other Name: aloxi

Detailed Description:
Intrathecal administration of morphine is often used for relief of postoperative pain. However, pruritus is one of the most common side effects associated with intrathecal morphine. Specific serotonin receptor antagonists such as ondansetron could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 19-70 years,
  • American Society of Anesthesiology physical status 1 and 2
  • Scheduled for elective urologic surgery under spinal anesthesia.

Exclusion Criteria:

  • Patients with cardiac and psychological problems.
  • Patients who take sedatives or narcotics.
  • Patient who have allergy to study drugs.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01952626


Locations
Korea, Republic of
Kyungpook National Hospital
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University
Investigators
Principal Investigator: Younghoon Jeon, Dr Kyungpook National University Hopsital
  More Information

Responsible Party: Younghoon Jeon, Associate professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01952626     History of Changes
Other Study ID Numbers: KNUH 2013-03-032-001
First Submitted: June 11, 2013
First Posted: September 30, 2013
Last Update Posted: April 9, 2015
Last Verified: April 2015

Keywords provided by Younghoon Jeon, Kyungpook National University:
intrathecal
morphine
ondansetron
palonosetron
pruritus

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Morphine
Ondansetron
Palonosetron
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents