Comparison of 0.8% sevoflurane versus Entonox for labour analgesia

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000805673
• Date of registration: 30/07/2014
• Prospective Registration: No
• Primary sponsor: University of Malaya
• Public title: Comparison of 0.8% sevoflurane versus Entonox for labour analgesia
• Scientific title: Comparison of 0.8% sevoflurane versus Entonox for labour analgesia
• Date of first enrolment: 01/05/2014
• Target sample size: 46
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12614000805673.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 2 / Phase 3

Countries of recruitment

Malaysia

Contacts

• Name: Prof Chan Yoo Kuen

• Name: Dr Kevin Ng Wei Shan

Key inclusion & exclusion criteria

Inclusion criteria: Healthy parturients in active labour with no medical or surgical comorbidities
Exclusion criteria: Any coexisting medical or surgical comorbities to mother and fetus

Age minimum: No limit
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Active Labour in healthy parturients;Post analgesic nausea and vomiting;Short term memory and amnesic effects of sevoflurane and entonox;
Active Labour in healthy parturients
Post analgesic nausea and vomiting
Short term memory and amnesic effects of sevoflurane and entonox

Reproductive Health and Childbirth - Normal pregnancy

Anaesthesiology - Pain management

Intervention(s)

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

Primary Outcome(s)

1) Overall pain experience
[Noted at 1hr post delivery and at 24 hours post delivery using a Visual analogue scale (VAS)]

2) Pain score during labour

[Hourly review of pain score using the VAS]

3) The need to use alternative analgesia[Other methods of analgesia required throughout labour]

Secondary Outcome(s)

4) Amnesia rate of both categories
[Done at end of delivery, assessed using picture recall method]

6) Blood loss
[Estimated blood loss at end of delivery]

3) Nausea and vomiting episodes in both categories of patients
[Nausea will be monitored hourly via a VAS
Vomiting will be monitored as number of episodes per hour
Overall nausea and vomiting will be measured at the end of delivery using the PONV Intensity scoring]

1) Maternal sedation score determined hourly through the labour experience
[Hourly during labour using the Wilson Sedation scale
]

7) Apgar score of baby[At end of delivery, to assess the effect of the intervention on the babies outcome.]

Cord blood pH[At end of third stage of labour, to assess condition of baby]

2) Blood pressure, heart rate and oxygen saturation

[Monitored hourly throughout labour using a DINAMAP blood pressure monitor and pulse oximetry]

5) Mode of delivery
[Comparing if the choice of analgesia will affect the mode of delivery, spontaneous vaginal delivery, LSCS, Assisted vaginal delivery via vacuum or forceps]

Secondary ID(s)

NMRR-14-139-19303 National Medical Research Registry, Malaysia

Source(s) of Monetary Support

University Of Malaya Research Grant

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee, University of Malaya Medical Centre