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

Kyungpook National University

Status: Completed

Conditions: Morphine Adverse Reaction

Treatments: Drug: Palonosetron; Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01952626

KNUH 2013-03-032-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups

ondansetron

Active Comparator group

Description:

Intravenous administration of ondansetron 4mg 15 minutes before spinal anesthesia

Treatment:

Drug: Ondansetron

palonosetron

Experimental group

Description:

Intravenous administration of palonosetron 0.075mg 15 minutes before spinal anesthesia

Treatment:

Drug: Palonosetron