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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Kyungpook National University
Sponsor:
Information provided by (Responsible Party):
Younghoon Jeon, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01952626
First received: June 11, 2013
Last updated: September 25, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Kyungpook National University:

Primary Outcome Measures:
  • Incidence of pruritus [ Time Frame: 24 hours after spinal anesthesia ] [ Designated as safety issue: No ]
    record of the incidence of pruritus after spinal anesthsia


Estimated Enrollment: 70
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated 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

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952626

Locations
Korea, Republic of
Kyungpook National Hospital Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Kibum Park, Dr    82534205877    pakkibum@naver.com   
Principal Investigator: Yougnhoon Jeon, Dr         
Sponsors and Collaborators
Kyungpook National University
Investigators
Principal Investigator: Younghoon Jeon, Dr Kyungpook National University Hopsital
  More Information

No publications provided

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
Study First Received: June 11, 2013
Last Updated: September 25, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on August 21, 2014