Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12614000805673
Ethics application status
Approved
Date submitted
6/04/2014
Date registered
30/07/2014
Date last updated
30/07/2014
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparison of 0.8% sevoflurane versus Entonox for labour analgesia
Query!
Scientific title
Comparison of 0.8% sevoflurane versus Entonox for labour analgesia
Query!
Secondary ID [1]
284399
0
NMRR-14-139-19303
National Medical Research Registry, Malaysia
Query!
Universal Trial Number (UTN)
U1111-1155-4304
Query!
Trial acronym
SEVONOX Study
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Active Labour in healthy parturients
291582
0
Query!
Post analgesic nausea and vomiting
291583
0
Query!
Short term memory and amnesic effects of sevoflurane and entonox
292467
0
Query!
Condition category
Condition code
Anaesthesiology
291961
291961
0
0
Query!
Pain management
Query!
Reproductive Health and Childbirth
292925
292925
0
0
Query!
Normal pregnancy
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
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
Query!
Intervention code [1]
289136
0
Treatment: Drugs
Query!
Comparator / control treatment
Entonox (nitrous oxide 50% in 50% oxygen) as an inhalational agent via facemask and using the Entonox inhaler
Entonox will be given throughout the duration of labour
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
291864
0
1) Overall pain experience
Query!
Assessment method [1]
291864
0
Query!
Timepoint [1]
291864
0
Noted at 1hr post delivery and at 24 hours post delivery using a Visual analogue scale (VAS)
Query!
Primary outcome [2]
292631
0
2) Pain score during labour
Query!
Assessment method [2]
292631
0
Query!
Timepoint [2]
292631
0
Hourly review of pain score using the VAS
Query!
Primary outcome [3]
292632
0
3) The need to use alternative analgesia
Query!
Assessment method [3]
292632
0
Query!
Timepoint [3]
292632
0
Other methods of analgesia required throughout labour
Query!
Secondary outcome [1]
307691
0
1) Maternal sedation score determined hourly through the labour experience
Query!
Assessment method [1]
307691
0
Query!
Timepoint [1]
307691
0
Hourly during labour using the Wilson Sedation scale
Query!
Secondary outcome [2]
309379
0
2) Blood pressure, heart rate and oxygen saturation
Query!
Assessment method [2]
309379
0
Query!
Timepoint [2]
309379
0
Monitored hourly throughout labour using a DINAMAP blood pressure monitor and pulse oximetry
Query!
Secondary outcome [3]
309380
0
3) Nausea and vomiting episodes in both categories of patients
Query!
Assessment method [3]
309380
0
Query!
Timepoint [3]
309380
0
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
Query!
Secondary outcome [4]
309381
0
4) Amnesia rate of both categories
Query!
Assessment method [4]
309381
0
Query!
Timepoint [4]
309381
0
Done at end of delivery, assessed using picture recall method
Query!
Secondary outcome [5]
309382
0
5) Mode of delivery
Query!
Assessment method [5]
309382
0
Query!
Timepoint [5]
309382
0
Comparing if the choice of analgesia will affect the mode of delivery, spontaneous vaginal delivery, LSCS, Assisted vaginal delivery via vacuum or forceps
Query!
Secondary outcome [6]
309383
0
6) Blood loss
Query!
Assessment method [6]
309383
0
Query!
Timepoint [6]
309383
0
Estimated blood loss at end of delivery
Query!
Secondary outcome [7]
309384
0
7) Apgar score of baby
Query!
Assessment method [7]
309384
0
Query!
Timepoint [7]
309384
0
At end of delivery, to assess the effect of the intervention on the babies outcome.
Query!
Secondary outcome [8]
309554
0
Cord blood pH
Query!
Assessment method [8]
309554
0
Query!
Timepoint [8]
309554
0
At end of third stage of labour, to assess condition of baby
Query!
Eligibility
Key inclusion criteria
Healthy parturients in active labour with no medical or surgical comorbidities
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Any coexisting medical or surgical comorbities to mother and fetus
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Trial explained and consent to participate in study obtained in antenatal clinic at 36weeks.
Upon presenting to the labour ward, the Patient is then reconsented and and randomised to either treatment arm.
Randomisation was done using a random number generator and the treatment arm is sealed in an opaque envelope and opened only upon randomisation
Patient will not be told which arm they are in. The investigators will not be blinded as the equipment to deliver the drug differs and is easily recognisable to the investigators. However our patients recruited would be exposed for the first time to such devices
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2 / Phase 3
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
From the paper by Yeo et al, pain relief score [median (range)]for sevoflurance was 67 (33-100) mm and Entonox 51([13-100)mm. Using the sample size calculator, OpenEpi; with power of 80% and significant level at 0.05, Median was approximate to mean, SD was calculated by using the formula of (max – min)/4;
Sample size 46; 23 in each arm
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/04/2014
Query!
Actual
1/05/2014
Query!
Date of last participant enrolment
Anticipated
30/04/2015
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
46
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
5967
0
Malaysia
Query!
State/province [1]
5967
0
Kuala Lumpur
Query!
Funding & Sponsors
Funding source category [1]
289046
0
University
Query!
Name [1]
289046
0
University Of Malaya Research Grant
Query!
Address [1]
289046
0
Faculty of Medicine,
University of Malaya,
Jalan Universiti
50603, Petaling Jaya
Kuala Lumpur
Query!
Country [1]
289046
0
Malaysia
Query!
Primary sponsor type
University
Query!
Name
University of Malaya
Query!
Address
University of Malaya,
Jalan Universiti
50603, Petaling Jaya
Kuala Lumpur
Query!
Country
Malaysia
Query!
Secondary sponsor category [1]
287715
0
None
Query!
Name [1]
287715
0
Query!
Address [1]
287715
0
Query!
Country [1]
287715
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
290843
0
Ethics Committee, University of Malaya Medical Centre
Query!
Ethics committee address [1]
290843
0
Jawatankuasa Etika Perubatan, Jabatan Kualiti Bahagian Pengurusan Risiko, Kompleks Pendidikan Sains Kejururawatan, Tingkat 1, Menara Utama Pusat Perubatan Universiti Malaya Lembah Pantai, 59100, Kuala Lumpur
Query!
Ethics committee country [1]
290843
0
Malaysia
Query!
Date submitted for ethics approval [1]
290843
0
Query!
Approval date [1]
290843
0
20/09/2013
Query!
Ethics approval number [1]
290843
0
1017.42
Query!
Summary
Brief 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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
47558
0
Prof Chan Yoo Kuen
Query!
Address
47558
0
Department of Anaesthesia,
Faculty of Medicine,
University of Malaya,
50603, Kuala Lumpur
Malaysia
Query!
Country
47558
0
Malaysia
Query!
Phone
47558
0
+60379492052
Query!
Fax
47558
0
Query!
Email
47558
0
[email protected]
Query!
Contact person for public queries
Name
47559
0
Kevin Ng Wei Shan
Query!
Address
47559
0
Department of Anaesthesia,
Faculty of Medicine,
University of Malaya,
50603, Kuala Lumpur
Malaysia
Query!
Country
47559
0
Malaysia
Query!
Phone
47559
0
+60122987708
Query!
Fax
47559
0
Query!
Email
47559
0
[email protected]
Query!
Contact person for scientific queries
Name
47560
0
Chan Yoo Kuen
Query!
Address
47560
0
Department of Anaesthesia,
Faculty of Medicine,
University of Malaya,
50603, Kuala Lumpur
Malaysia
Query!
Country
47560
0
Malaysia
Query!
Phone
47560
0
+60379492052
Query!
Fax
47560
0
Query!
Email
47560
0
[email protected]
Query!
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Ng, K. W. S.1,*; Chan, Y.1; Shariffuddin, I. I.1; ...
[
More Details
]
Documents added automatically
No additional documents have been identified.
Download to PDF