Intravenous Remifentanil for Labor Analgesia

NCT ID: NCT00710086

Last Updated: 2009-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Intravenous administration of hydromorphone intermittently

Group Type: ACTIVE_COMPARATOR

Hydromorphone

Intervention Type: DRUG

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

2

Remifentanil intravenous patient-controlled analgesia

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

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

Interventions

Hydromorphone

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

Intervention Type: DRUG

Remifentanil

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

Intervention Type: DRUG

Other Intervention Names

ReiFen

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

HRSA/Maternal and Child Health Bureau

FED

Sponsor Role: collaborator

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Nanjing Medical University

Principal Investigators

XiaoFeng Shen, MD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NSR083

Identifier Type: -

Identifier Source: secondary_id

NJFY-08021MZ

Identifier Type: -

Identifier Source: org_study_id