Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section

Conditions

• Pruritus Caused by Drug

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Ondansetron 8mg — DRUG
  administration of an IV solution of 8mg ondansetron (4ml)

Study Details

Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.

Key Dates

Start date

Aug 22, 2024

Status verified

Mar 2025

Primary completion

Aug 1, 2025

Completion

Dec 1, 2025

Study Design

Enrollment

66 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group 1. Pre-Intrathecal
  Patients will receive an IV solution of 8mg ondansetron (4ml) within 30 minutes of the standard-of-care anesthetic treatment (intrathecal morphine administration) followed by a placebo treatment of an IV solution of 4ml 0.9% saline administered at the time of umbilical cord clamping.
• Active Comparator: Treatment Group 2 Cord clamping
  Patients will receive a placebo treatment of an IV solution of 4ml 0.9% saline administered within 30 minutes of the standard-of-care anesthetic treatment (intrathecal morphine administration) followed by an IV solution of 8mg ondansetron (4ml) administered at the time of umbilical cord clamping.

Primary Outcome Measure

Pruritus parameters in Post anesthesia Care Unit (PACU) [ Time Frame: Assessment during 1st post-operative hour in PACU ]

Central Contacts

• Justin Hruska, MD
  402-432-0985
  [email protected]
• George M McKelvey, PhD
  3135986036
  [email protected]

Locations (1)

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