Skip to main content
OpenTrials
Completed

NCT Number: NCT00710086

Intravenous Remifentanil for Labor Analgesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nulliparous women
  • > 18 years and < 45 years
  • Spontaneous labor
  • Analgesia request
  • Epidural puncture contraindications
  • Tendency of bleeding

Exclusion criteria

  • Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
  • Participants younger than 18 years or older than 45 years
  • Those who were not willing to or could not finish the whole study at any time
  • Using or used in the past 14 days of the monoamine oxidase inhibitors
  • Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
  • Subjects with a nonvertex presentation or scheduled induction of labor
  • Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization
  • Diagnosed diabetes mellitus and pregnancy-induced hypertension
  • Twin gestation and breech presentation

Treatment and study plan

Hydromorphone

Drug

Intravenous administration of hydromorphone 1mg at the patient's request if they felt uterine contraction pain

Remifentanil

Drug

Remifentanil intravenous PCA: 0.2μg/kg, lockout time interval 2 minutes, continuous infusion rate 0.2-0.8μg/kg/min.

Other names: ReiFen

Primary outcomes

  1. 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 outcomes

  1. Rate of cesarean delivery

    Time frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)

  2. Rate of instrument-assisted delivery

    Time frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)

  3. Indications of cesarean delivery

    Time frame: Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals)

  4. Duration of analgesia

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

  5. Maternal satisfaction with analgesia

    Time frame: At the end of the vaginal delivery (this time period underwent changing in different individuals)

  6. Maternal oral temperature

    Time frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)

  7. Use of oxytocin after analgesia

    Time frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)

  8. Maximal oxytocin dose

    Time frame: At the end of vaginal delivery (this time period underwent changing in different individuals)

  9. Breastfeeding success at 6 weeks after vaginal delivery

    Time frame: At the sixth week after successful delivery

  10. Neonatal one-minute Apgar scale

    Time frame: At the first minute of baby was born

  11. Neonatal five-minute Apgar scale

    Time frame: At the fifth minute of baby was born

  12. Umbilical-cord gases analysis

    Time frame: At the time baby was born (0 min)

  13. Neonatal sepsis evaluation

    Time frame: After the baby was born (15 min after delivery)

  14. Neonatal antibiotic treatment

    Time frame: After the baby was born (one day after delivery)

  15. Incidence of maternal side effects

    Time frame: Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

Remifentanil Intravenous Patient-controlled Labor Analgesia for Nulliparous Women

Acronym: IRELAN

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 4, 2008
Registry last updated
Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.