Intravenous Remifentanil for Labor Analgesia

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00710086
• Date of registration: 02/07/2008
• Primary sponsor: Nanjing Medical University
• Public title: Intravenous Remifentanil for Labor Analgesia IRELAN
• Scientific title: Remifentanil Intravenous Patient-controlled Labor Analgesia for Nulliparous Women
• Date of first enrolment: July 2008
• Target sample size: 1000
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00710086
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: XiaoFeng Shen, MD
• Affiliation: Nanjing Medical University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Nulliparous women

2. > 18 years and < 45 years

3. Spontaneous labor

4. Analgesia request

5. Epidural puncture contraindications

6. Tendency of bleeding

Exclusion Criteria:

1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort,
chronic pain and psychiatric diseases records

2. Participants younger than 18 years or older than 45 years

3. Those who were not willing to or could not finish the whole study at any time

4. Using or used in the past 14 days of the monoamine oxidase inhibitors

5. Alcohol addictive or narcotic dependent patients were excluded for their influence on
the analgesic efficacy of the epidural analgesics

6. Subjects with a nonvertex presentation or scheduled induction of labor

7. Cervical dilation was 5.0cm or greater before performing epidural puncture and
catheterization

8. Diagnosed diabetes mellitus and pregnancy-induced hypertension

9. Twin gestation and breech presentation



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Labor Pain

Intervention(s)

Drug: Hydromorphone

Drug: Remifentanil

Primary Outcome(s)

Maternal Visual Analog Scale (VAS) rating of pain [Time Frame: Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery]

Secondary Outcome(s)

Breastfeeding success at 6 weeks after vaginal delivery [Time Frame: At the sixth week after successful delivery]

Duration of analgesia [Time Frame: Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals)]

Incidence of maternal side effects [Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)]

Indications of cesarean delivery [Time Frame: Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals)]

Maternal oral temperature [Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)]

Maternal satisfaction with analgesia [Time Frame: At the end of the vaginal delivery (this time period underwent changing in different individuals)]

Maximal oxytocin dose [Time Frame: At the end of vaginal delivery (this time period underwent changing in different individuals)]

Neonatal antibiotic treatment [Time Frame: After the baby was born (one day after delivery)]

Neonatal five-minute Apgar scale [Time Frame: At the fifth minute of baby was born]

Neonatal one-minute Apgar scale [Time Frame: At the first minute of baby was born]

Neonatal sepsis evaluation [Time Frame: After the baby was born (15 min after delivery)]

Rate of cesarean delivery [Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)]

Rate of instrument-assisted delivery [Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)]

Umbilical-cord gases analysis [Time Frame: At the time baby was born (0 min)]

Use of oxytocin after analgesia [Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)]

Secondary ID(s)

NJFY-08021MZ

NSR083

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

HRSA/Maternal and Child Health Bureau