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

Morphine Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952626
• Other study ID #: KNUH 2013-03-032-001
• Status: Completed
• Phase: N/A
• First received: June 11, 2013
• Last updated: April 7, 2015
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Morphine Adverse Reaction
• Pruritus

Intervention

Drug:
• Ondansetron
intravenous injection
• Palonosetron
intravenous injection

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pruritus	record of the incidence of pruritus after spinal anesthsia	24 hours after spinal anesthesia	No