Intravenous Remifentanil for Labor Analgesia (IRELAN)

This study has been completed.
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00710086
First received: July 2, 2008
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

Labor analgesia is an essential health caring procedure for women. However, epidural analgesia cannot be performed on all subjects for different contraindications, such as lower platelet counter, back infection at the puncture site, and fear of epidural injection etc. Therefore, intravenous analgesia is an alternative for such conditions. Given the influence of intravenous administration of drugs on fetus, the drug selection is very important. Remifentanil, a super-short efficacious opioid, can last for 3-4 minutes after injection, which is similar in both maternal and fetal environment. Thus the fetus-associated side effects would be less than other drugs. The investigators hypothesized that remifentanil would be a superior intravenous drug used with patient-controlled technique for labor analgesia.


Condition Intervention Phase
Labor Pain
Drug: Hydromorphone
Drug: Remifentanil
Phase 4

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
Official Title: Remifentanil Intravenous Patient-controlled Labor Analgesia for Nulliparous Women

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of cesarean delivery [ Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) ] [ Designated as safety issue: Yes ]
  • Rate of instrument-assisted delivery [ Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) ] [ Designated as safety issue: Yes ]
  • Indications of cesarean delivery [ Time Frame: Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals) ] [ Designated as safety issue: Yes ]
  • Duration of analgesia [ Time Frame: Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals) ] [ Designated as safety issue: Yes ]
  • Maternal satisfaction with analgesia [ Time Frame: At the end of the vaginal delivery (this time period underwent changing in different individuals) ] [ Designated as safety issue: No ]
  • Maternal oral temperature [ Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) ] [ Designated as safety issue: Yes ]
  • Use of oxytocin after analgesia [ Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) ] [ Designated as safety issue: Yes ]
  • Maximal oxytocin dose [ Time Frame: At the end of vaginal delivery (this time period underwent changing in different individuals) ] [ Designated as safety issue: No ]
  • Breastfeeding success at 6 weeks after vaginal delivery [ Time Frame: At the sixth week after successful delivery ] [ Designated as safety issue: Yes ]
  • Neonatal one-minute Apgar scale [ Time Frame: At the first minute of baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal five-minute Apgar scale [ Time Frame: At the fifth minute of baby was born ] [ Designated as safety issue: Yes ]
  • Umbilical-cord gases analysis [ Time Frame: At the time baby was born (0 min) ] [ Designated as safety issue: Yes ]
  • Neonatal sepsis evaluation [ Time Frame: After the baby was born (15 min after delivery) ] [ Designated as safety issue: Yes ]
  • Neonatal antibiotic treatment [ Time Frame: After the baby was born (one day after delivery) ] [ Designated as safety issue: Yes ]
  • Incidence of maternal side effects [ Time Frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) ] [ Designated as safety issue: Yes ]

Enrollment: 1000
Study Start Date: July 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Intravenous administration of hydromorphone intermittently
Drug: Hydromorphone
Intravenous administration of hydromorphone 1mg at the patient's request if they felt uterine contraction pain
Experimental: 2
Remifentanil intravenous patient-controlled analgesia
Drug: Remifentanil
Remifentanil intravenous PCA: 0.2μg/kg, lockout time interval 2 minutes, continuous infusion rate 0.2-0.8μg/kg/min.
Other Name: ReiFen

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710086

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
HRSA/Maternal and Child Health Bureau
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00710086     History of Changes
Other Study ID Numbers: NJFY-08021MZ, NSR083
Study First Received: July 2, 2008
Last Updated: September 17, 2009
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Remifentanil
Patient-controlled analgesia
Intravenous analgesia

Additional relevant MeSH terms:
Labor Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Hydromorphone
Remifentanil
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014