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The safety and efficacy of intramuscular acetaminophen with hyoscine butylbromide versus intramuscular pentazocine for labour pain management in University of Nigerian Teaching Hospital (UNTH) Ituku-Ozala, Enugu, Nigeria: a double -blind randomized controlled trial

Safety and efficacy of intramuscular acetaminophen with hyoscine butylbromide versus intramuscular pentazocine for labour pain management in University of Nigerian Teaching Hospital (UNTH) Ituku-Ozala, Enugu, Nigeria: a double -blind randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202506913477224
Enrollment
180
Registered
2025-06-23
Start date
2024-12-17
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Pregnancy and Childbirth

Interventions

Paracetamol hyoscine butyl bromide

Sponsors

Eze Jeremiah
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. The patient will be booked and will be attending antenatal care at UNTH 2. The pregnancy has to be between the gestational age of 37 week to 42 weeks and vagina delivery is anticipated 3. The patient has to be admitted in labour with cervical dilatation of 4–6 cm 4. Patient who has given written consent.

Exclusion criteria

Exclusion criteria: 1. Patient who is not booked and who is not attending antenatal care at UNTH 2. Patient that is allergic to pentazocine, paracetamol or hyoscine butylbromide 3. Patient who has contraindication to vagina delivery. 4. Pregnancy complicated by fetal distress at recruitment 5. Maternal conditions such as cardiopulmonary depression 6. History of recent/chronic liver disease. 7. History of renal disease 8. Those with prior analgesic administration will be excluded from the study. 9. Patients with history of adverse reaction to the medications

Design outcomes

Primary

MeasureTime frame
1.The mean pain score between women who will have intramuscular paracetamol with intramuscular hyoscine butylbromide versus women who will have intramuscular pentazocine as labour analgesia. 2.Safety between women who will have intramuscular paracetamol with intramuscular hyoscine butylbromide versus women who will receive intramuscular pentazocine as labour analgesia

Secondary

MeasureTime frame
1. Maternal satisfaction with pain relief between the two groups 2. Duration of labour among the participants 3. Incidence of maternal/neonatal complications among the participants. 4. Delivery routes among the participants.

Countries

Nigeria

Contacts

Public ContactProf. Ajah Leonard

Consultant

leokpanku@yahoo.com08033920789

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026