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

Not Applicable

Completed

• Conditions: Morphine Adverse Reaction
• Interventions: Drug: Palonosetron; Drug: Ondansetron

• Registration Number: NCT01952626
• Lead Sponsor: Kyungpook National University Hospital

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-09-30
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Read More

Exclusion Criteria

• Patients with cardiac and psychological problems.
• Patients who take sedatives or narcotics.
• Patient who have allergy to study drugs.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
palonosetron	Palonosetron	Intravenous administration of palonosetron 0.075mg 15 minutes before spinal anesthesia
ondansetron	Ondansetron	Intravenous administration of ondansetron 4mg 15 minutes before spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Incidence of pruritus	24 hours after spinal anesthesia	record of the incidence of pruritus after spinal anesthsia

Trial Locations

Locations (1)

Kyungpook National Hospital; 🇰🇷 Daegu, Korea, Republic of