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

Primary Purpose

Morphine Adverse Reaction

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ondansetron
Palonosetron
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morphine Adverse Reaction focused on measuring intrathecal, morphine, ondansetron, palonosetron, pruritus

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kyungpook National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ondansetron

palonosetron

Arm Description

Intravenous administration of ondansetron 4mg 15 minutes before spinal anesthesia

Intravenous administration of palonosetron 0.075mg 15 minutes before spinal anesthesia

Outcomes

Primary Outcome Measures

Incidence of pruritus
record of the incidence of pruritus after spinal anesthsia

Secondary Outcome Measures

Full Information

First Posted
June 11, 2013
Last Updated
April 7, 2015
Sponsor
Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01952626
Brief Title
Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron
Official Title
Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morphine Adverse Reaction
Keywords
intrathecal, morphine, ondansetron, palonosetron, pruritus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ondansetron
Arm Type
Active Comparator
Arm Description
Intravenous administration of ondansetron 4mg 15 minutes before spinal anesthesia
Arm Title
palonosetron
Arm Type
Experimental
Arm Description
Intravenous administration of palonosetron 0.075mg 15 minutes before spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
zofran
Intervention Description
intravenous injection
Intervention Type
Drug
Intervention Name(s)
Palonosetron
Other Intervention Name(s)
aloxi
Intervention Description
intravenous injection
Primary Outcome Measure Information:
Title
Incidence of pruritus
Description
record of the incidence of pruritus after spinal anesthsia
Time Frame
24 hours after spinal anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Younghoon Jeon, Dr
Organizational Affiliation
Kyungpook National University Hopsital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook National Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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