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

NCT ID: NCT01952626

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-06-30

Brief Summary

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.

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.

Conditions

Morphine Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ondansetron

Intravenous administration of ondansetron 4mg 15 minutes before spinal anesthesia

Group Type: ACTIVE_COMPARATOR

Ondansetron

Intervention Type: DRUG

intravenous injection

palonosetron

Intravenous administration of palonosetron 0.075mg 15 minutes before spinal anesthesia

Group Type: EXPERIMENTAL

Palonosetron

Intervention Type: DRUG

intravenous injection

Interventions

Ondansetron

intravenous injection

Intervention Type: DRUG

Palonosetron

intravenous injection

Intervention Type: DRUG

Other Intervention Names

zofran; aloxi

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyungpook National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Younghoon Jeon

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Younghoon Jeon, Dr

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hopsital

Locations

Kyungpook National Hospital

Daegu, , South Korea

Countries

South Korea

Other Identifiers

KNUH 2013-03-032-001

Identifier Type: -

Identifier Source: org_study_id