RecruitingPhase 2Phase 3ACTRN12614000805673

Comparison of 0.8% sevoflurane versus Entonox for labour analgesia


Sponsor

University of Malaya

Enrollment

46 participants

Start Date

May 1, 2014

Study Type

Interventional

Conditions

Summary

Labour analgesia in the form of epidural would be ideal for all parturients but this being expensive to provide is limited in supply to only about 1% of the Malaysian population. Dose finding studies have shown that 0.8% sevoflurane administered to a parturient can provide substantial analgesia. A commercially available 0.8% inhaler has just emerged in the market. We would like to compare this method with the traditional option of using Entonox. In this study we propose to compare the pain experience of parturients exposed to either 0.8% sevoflurane or entonox. We expect the 0.8% inhaler to provide better analgesia for the mother. We do not expect any untoward complications to arise from its use. The costing results will be unknown until after the study.


Eligibility

Sex: Females

Plain Language Summary

Simplified for easier understanding

This study compares two methods of pain relief during labor: breathing in a gas called Entonox (laughing gas) versus using a new inhaler device that delivers 0.8% sevoflurane. Both methods are used by mothers during contractions to reduce pain without an epidural. You may be eligible if: - You are a healthy woman in active labor - You have no significant medical or surgical health conditions You may NOT be eligible if: - You have any medical or surgical health conditions that could affect you or your baby Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Comparison of sevoflurane 0.8% and nitrous oxide 50% in oxygen for labour analgesia. Sevoflurane 0.8% will be administered as an inhalational agent using the Diamedica draw over vaporiser with a fixed

Comparison of sevoflurane 0.8% and nitrous oxide 50% in oxygen for labour analgesia. Sevoflurane 0.8% will be administered as an inhalational agent using the Diamedica draw over vaporiser with a fixed concentration of 0.8% in air. Entonox will be administered via the Entonox inhaler attached to the hospital wall supply. Both agents will be given as patient controlled inhalers throughout the duration of labour


Locations(1)

Kuala Lumpur, Malaysia

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ACTRN12614000805673