Intravenous Remifentanil for Labor Analgesia

Condition(s) targeted: Labor Pain

Intervention: Hydromorphone (Drug); Remifentanil (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Nanjing Medical University

Official(s) and/or principal investigator(s):
XiaoFeng Shen, MD, Study Director, Affiliation: Nanjing Medical University

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Maternal Visual Analog Scale (VAS) rating of pain

Secondary outcome:

Rate of cesarean delivery

Rate of instrument-assisted delivery

Indications of cesarean delivery

Duration of analgesia

Maternal satisfaction with analgesia

Maternal oral temperature

Use of oxytocin after analgesia

Maximal oxytocin dose

Breastfeeding success at 6 weeks after vaginal delivery

Neonatal one-minute Apgar scale

Neonatal five-minute Apgar scale

Umbilical-cord gases analysis

Neonatal sepsis evaluation

Neonatal antibiotic treatment

Incidence of maternal side effects

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Nanjing Maternal and Child Health Care Hospital, Nanjing, Jiangsu 210004, China

Starting date: July 2008
Last updated: September 17, 2009