Intravenous Remifentanil for Labor Analgesia

NCT00710086 | Completed Phase 4 DMC

• 2 other identifiers: NJFY-08021MZNSR083
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain

Keywords

Remifentanil; Patient-controlled analgesia; Intravenous analgesia

Outcome Measures

Primary Outcomes (1)

• Maternal Visual Analog Scale (VAS) rating of pain

  Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery

Secondary Outcomes (15)

• Rate of cesarean delivery

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

• Rate of instrument-assisted delivery

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

• Indications of cesarean delivery

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

• Duration of analgesia

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

• Maternal satisfaction with analgesia

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

Study Arms (2)

1

ACTIVE COMPARATOR

Intravenous administration of hydromorphone intermittently

Drug: Hydromorphone

2

EXPERIMENTAL

Remifentanil intravenous patient-controlled analgesia

Drug: Remifentanil

Interventions

Hydromorphone DRUG

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

1

Remifentanil DRUG

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

Also known as: ReiFen

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead
• HRSA/Maternal and Child Health Bureau: collaborator

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Hydromorphone; Remifentanil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• XiaoFeng Shen, MD

  Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

CN (1)