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comparative study between effect of Nalbuphine versus Ondansetron for prevention of intrathecal opioid induced pruritus after cesarean delivery: A Randomized controlled trial

comparative study between effect of Nalbuphine versus Ondansetron for prevention of intrathecal opioid induced pruritus after cesarean delivery: A Randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241022009
Enrollment
94
Registered
2024-10-22
Start date
2024-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pruritus after caesarean delivery pruritus after caesarean delivery

Interventions

administration nalbuphine 3 mg iv. after cord cut,administration ondansetron 8 mg iv. after cord cut
Active Comparator Drug,Placebo Comparator Drug
Nalbuphine,Ondansetron

Sponsors

Anesthesiologist
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: Thai patients or foreign patients who can communicate in Thai, aged 20 years and older, undergoing elective cesarean section at a gestational age of 38 weeks or more, with spinal anesthesia

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications for spinal anesthesia include those with infections at the procedure site, elevated intracranial pressure, abnormal bleeding disorders, heart disease, and patients with pre-existing neurological conditions. 2. Patients with a history of allergy to the drugs used in the study, including Nalbuphine, Ondansetron, Morphine, and Bupivacaine. 3. Patients with kidney disease, liver disease, and asthma. 4.Contraindications for the procedure include patients with abnormal bleeding conditions and infections at the procedure site. 5.Patients who refuse to participate in the research. 6.BMI more than 40 kilograms per meter squared

Design outcomes

Primary

MeasureTime frame
pruritus score at recover room, 6 and 24 hour after spinal anesthesia Pruritus intensity scale

Secondary

MeasureTime frame
Nausea vomiting score at recover room, 6 and 24 hour after spinal anesthesia Nausea vomiting scale,pain at recover room, 6 and 24 hour after spinal anesthesia Visual analogue scale,sedation at recover room, 6 and 24 hour after spinal anesthesia sedation score

Countries

Thailand

Contacts

Public Contactkingkarn Wannasiri

Phrapokklao Hospital

medkingko@gmail.com0891771604

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026