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

NCT01952626 | Completed DMC

• 1 other identifier: KNUH 2013-03-032-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Morphine Adverse Reaction

Keywords

intrathecal; morphine; ondansetron; palonosetron; pruritus

Outcome Measures

Primary Outcomes (1)

• Incidence of pruritus

  record of the incidence of pruritus after spinal anesthsia

  24 hours after spinal anesthesia

Study Arms (2)

ondansetron

ACTIVE COMPARATOR

Intravenous administration of ondansetron 4mg 15 minutes before spinal anesthesia

Drug: Ondansetron

palonosetron

EXPERIMENTAL

Intravenous administration of palonosetron 0.075mg 15 minutes before spinal anesthesia

Drug: Palonosetron

Interventions

Ondansetron DRUG

intravenous injection

Also known as: zofran

ondansetron

Palonosetron DRUG

intravenous injection

Also known as: aloxi

palonosetron

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (1)

Kyungpook National Hospital

Daegu, 700-721, South Korea

Location

MeSH Terms

Conditions

Pruritus

Interventions

Ondansetron; Palonosetron

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines

Study Officials

• Younghoon Jeon, Dr

  Kyungpook National University Hopsital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: September 30, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

KR (1)