PainNCT01563939
Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour
A study testing Remifentanil in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Epidural analgesia for pain relief in labor may not be suitable for all patients, and intravenous patient controlled analgesia (IV PCA) with opioids offers the best alternative. The purpose of this study is to assess the effectiveness of two methods remifentanil administration in the form of either an infusion or PCA… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Term pregnancy in labour with singleton fetus in cephalic presentation
- Patients requesting systemic analgesia
- Patients with contraindication for regional anesthesia without fetal compromise (coagulopathy, thrombocytopenia, refusal, etc.)
Who cannot join
- Refusal to sign written informed consent
- Inability to communicate in English
- Opioid dependence or addiction
- Patients on Methadone
- Allergy or hypersensitivity to remifentanil
- Fetal heart rate abnormalities
- Fetal congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour: is Demand Bolus Required for Optimal Analgesia
Epidural analgesia for pain relief in labor may not be suitable for all patients, and intravenous patient controlled analgesia (IV PCA) with opioids offers the best alternative. The purpose of this study is to assess the effectiveness of two methods remifentanil administration in the form of either an infusion or PCA demand bolus (intravenous injection of a single dose over a short period of time). Currently, our hospital gives remifentanil by demand bolus, however it may be equally effective, with less side effects, to give the drug as an infusion.
Read the detailed description
The study will be conducted as a randomized trial with two arms: Group I- continuous infusion of remifentanil with stepwise increase in infusion rates and Group II- demand bolus only with stepwise increase in bolus dose, as per the patient's analgesic requirement. Visual analog scores will be the primary outcome. Maternal and fetal side effects will be recorded. The results of this study will determine the regimen that suits the patients needs for painless labor with high efficacy, less adverse effects and a higher patient satisfaction.
- Conditions
- Pain
- Being tested
- Remifentanil
- Keywords
- Labour analgesia, Pregnancy, IVPCA
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called remifentanil hydrochloride
Remifentanil IV for continuous infusion: 0.025mcg/kg/min, increased by 0.025mcg/kg/min every 15 min if patient is not satisfied, to a maximum of 0.15mcg/kg/min.
Remifentanil IV for demand bolus: 0.2 mcg/kg, lockout 2 min, incrementally increased if patient is not satisfied by 0.2 mcg/kg to a maximum of 1.2 mcg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Continuous infusion | Active comparator | Remifentanil administered by continuous IV infusion, with stepwise increase in infusion rates and placebo demand bolus of normal saline. Receives: Drug: Remifentanil |
| Demand Bolus | Active comparator | Demand bolus of remifentanil with stepwise increase in bolus dose and placebo continuous infusion of normal saline. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Verbal Numeric Rating Scale (VNRS) from 0 to 10 (where 0 = no pain and 10 = worst pain felt), approximately every hour, throughout labour.
Measured: 24 hours
Secondary outcomes (5)
Maternal satisfaction
Maternal satisfaction rated from 0-10, throughout labour
Measured: 24 hours
Consumption of remifentanil
remifentanil consumed in mg/hr
Measured: 24 hours
Crossover to epidural
Time to crossover if the patient decides to have an epidural
Measured: 24 hours
Side effects
Sedation score, Heart Rate, Blood Pressure, Nausea, Vomiting, Pruritis
Measured: 24 hours
Fetal & Neonatal outcomes
Non-reassuring fetal heart rate as determined by obstetrician, Neonatal weight, Apgar scores, naloxone administration, need for resuscitation, NICU admission.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Difficult recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mrinalini Balki, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563939
- Sponsor's protocol ID
- 12-02
- Status last verified
- Sep 2015
- First submitted
- 23 Mar 2012
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour: is Demand Bolus Required for Optimal Analgesia
- ClinicalTrials.gov ID
- NCT01563939
- Acronym / sponsor ID
- 12-02
- Conditions
- Pain
- Keywords
- Labour analgesia, Pregnancy, IVPCA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult recruitment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epidural analgesia for pain relief in labor may not be suitable for all patients, and intravenous patient controlled analgesia (IV PCA) with opioids offers the best alternative. The purpose of this study is to assess the effectiveness of two methods remifentanil administration in the form of either an infusion or PCA demand bolus (intravenous injection of a single dose over a short period of time). Currently, our hospital gives remifentanil by demand bolus, however it may be equally effective, with less side effects, to give the drug as an infusion.
Detailed description
The study will be conducted as a randomized trial with two arms: Group I- continuous infusion of remifentanil with stepwise increase in infusion rates and Group II- demand bolus only with stepwise increase in bolus dose, as per the patient's analgesic requirement. Visual analog scores will be the primary outcome. Maternal and fetal side effects will be recorded. The results of this study will determine the regimen that suits the patients needs for painless labor with high efficacy, less adverse effects and a higher patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous infusion | Active comparator | Drug: RemifentanilRemifentanil administered by continuous IV infusion, with stepwise increase in infusion rates and placebo demand bolus of normal saline. |
| Demand Bolus | Active comparator | Drug: RemifentanilDemand bolus of remifentanil with stepwise increase in bolus dose and placebo continuous infusion of normal saline. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent
- Term pregnancy in labour with singleton fetus in cephalic presentation
- Patients requesting systemic analgesia
- Patients with contraindication for regional anesthesia without fetal compromise (coagulopathy, thrombocytopenia, refusal, etc.)
Key exclusion criteria (7 listed)
- Refusal to sign written informed consent
- Inability to communicate in English
- Opioid dependence or addiction
- Patients on Methadone
- Allergy or hypersensitivity to remifentanil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilAlso: remifentanil hydrochlorideRemifentanil IV for continuous infusion: 0.025mcg/kg/min, increased by 0.025mcg/kg/min every 15 min if patient is not satisfied, to a maximum of 0.15mcg/kg/min. Remifentanil IV for demand bolus: 0.2 mcg/kg, lockout 2 min, incrementally increased if patient is not satisfied by 0.2 mcg/kg to a maximum of 1.2 mcg/kg. | Drug | Continuous infusion, Demand Bolus |
Primary outcome
Pain score
Time frame: 24 hours
Verbal Numeric Rating Scale (VNRS) from 0 to 10 (where 0 = no pain and 10 = worst pain felt), approximately every hour, throughout labour.
5 secondary outcomes
Maternal satisfaction
Time frame: 24 hours
Consumption of remifentanil
Time frame: 24 hours
Crossover to epidural
Time frame: 24 hours
Side effects
Time frame: 24 hours
Fetal & Neonatal outcomes
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Difficult recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mrinalini Balki, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficult recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.