VPIA Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration
Novel Vital-sign Patient-assisted Intravenous Analgesia With Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration: a Prospective Cohort Study
1 other identifier
interventional
25
1 country
1
Brief Summary
This study is a prospective cohort study aiming to evaluate an improved VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2015
CompletedFirst Posted
Study publicly available on registry
April 12, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedFebruary 7, 2017
January 1, 2017
1 year
December 30, 2015
February 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Maternal desaturation
Duration of labour
Secondary Outcomes (2)
Maternal bradycardia
Duration of labour, an expected average of 24 hours
Apnoea/hypopnoea
Duration of labour, an expected average of 24 hours
Other Outcomes (10)
Side effects: pruritus
Duration of labour, an expected average of 24 hours
Side effects: nausea vomiting
Duration of labour, an expected average of 24 hours
Side effects: sedation
Duration of labour, an expected average of 24 hours
- +7 more other outcomes
Study Arms (1)
Remifentanil
EXPERIMENTALRemifentanil Patient Controlled Analgesia
Interventions
Vital signs-controlled, patient assisted intravenous analgesia using remifentanil
Eligibility Criteria
You may qualify if:
- Patients who choose to use parenteral opioid for pain relief with informed consent
- Patients who refuse labour epidural analgesia or with contraindication to epidural analgesia (eg. thrombocytopaenia, previous thoraco-lumbar spinal instrumentation)
- Gestational age of \>= 36 weeks
You may not qualify if:
- Patients who are unable to understand instructions given regarding the use of patient controlled analgesia (PCA) or unable to self administer PCA boluses
- Patients with difficulty in communication due to language differences
- Patients with known hypersensitivity to remifentanil or any component of its formulation or to other fentanyl analogue
- Patients with severe respiratory disease
- Patients with history of drug dependence of recreational drug abuse
- Patients with unmanaged foetal bradycardia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KK Women's and Children's Hospital
Singapore, Singapore, 229899, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wan Ling Leong, MBBS FANZCA
KK Women's and Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2015
First Posted
April 12, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2017
Study Completion
March 1, 2018
Last Updated
February 7, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share