NCT05565274

Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients

Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients in the Federal Medical Center, Yenagoa, Bayelsa State, Southern Nigeria: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Federal Medical Centre, Yenagoa · Other Government
• Sex: Female
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Labour is a very painful experience and epidural analgesia is considered the gold standard for pain relief in labour. Epidural scarcity, cost and shortage of skilled personnel to administer it is a limitation to it's usage in developing countries. Parenteral opioid analgesics such as pethidine and pentazocine are effective labour analgesia commonly used in developing countries but are limited by their side effects. This limitation in their use call for the need for alternative analgesic with similar or superior analgesic effect but with minimal side effects.The study is aimed at evaluating the efficacy and safety of combined tramadol and paracetamol in reducing labour pain among parturients.

Detailed description

There is paucity of data in our environment looking at the efficacy and safety of combined tramadol and paracetamol in relieving labour pain. This study will offer us great opportunity to evaluate their synergistic effect in labour when compared to the commonly used single opioids such as pethidine or pentazocine. It would be a double blinded randomized controlled trial. One hundred and sixty-six pregnant eligible women in labour would participate in this study. Participants will be randomized equally into two study arms ( Tramadol plus Paracetamol study arm and Pentazocine study arm) after informed consent. The Tramadol plus Paracetamol study arm will receive 100mg of tramadol plus 600mg of paracetamol intramuscularly in a 2ml and 5ml syringe respectively while the pentazocine study arm will receive 30mg of Pentazocine and 2 milliliters of water for injection as placebo intramuscularly in a 2l and 5 ml syringes respectively. Both drugs will be administered to the participants at 4-6cm cervical dilatation during labour. The outcome measures will be evaluated within 5 hours in labour and an hour immediately after delivery. The need for additional rescue analgesia will be assessed as well. Fetal outcome on both arms will be noted too.

Conditions

• Labor Pain

Interventions

Type	Name	Description
DRUG	Pentazocine plus placebo	30mg of pentazocine and 2milliLitre of injection water

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2022-10-04
• Last updated: 2022-10-04