VPIA Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration

KK Women's and Children's Hospital

Status and phase

Unknown

Phase 4

Conditions

Labor Pain

Treatments

Drug: Remifentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT02733835

CIRB/2015/2352

Details and patient eligibility

About

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

Full description

This study trials a new Vital signs-controlled patient-assisted intravenous analgesia (VPIA) regimen using a purpose-built pump that aims to enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. The system studies the parturient's pattern of analgesic use in 15 minute epochs and titrates the demand doses and basal infusion rate to maintain a plasma level of remifentanil that is appropriate for the degree of pain felt.

The system incorporates vital signs (pulse oximetry and heart rate values) into the algorithm which would temporarily stop the pump and step down doses accordingly when predefined critical values are reached.

Enrollment

25 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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