Intravenous Remifentanil for Labor Analgesia

Labor Pain Clinical Trial

— IRELAN  

Official title:

Remifentanil Intravenous Patient-controlled Labor Analgesia for Nulliparous Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710086
• Other study ID #: NJFY-08021MZ
• Secondary ID: NSR083
• Status: Completed
• Phase: Phase 4
• First received: July 2, 2008
• Last updated: September 17, 2009
• Start date: July 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Hydromorphone
Intravenous administration of hydromorphone 1mg at the patient's request if they felt uterine contraction pain
• Remifentanil
Remifentanil intravenous PCA: 0.2µg/kg, lockout time interval 2 minutes, continuous infusion rate 0.2-0.8µg/kg/min.

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing Medical University	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Visual Analog Scale (VAS) rating of pain		Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery	Yes
Secondary	Rate of cesarean delivery		Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)	Yes
Secondary	Rate of instrument-assisted delivery		Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)	Yes
Secondary	Indications of cesarean delivery		Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals)	Yes
Secondary	Duration of analgesia		Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals)	Yes
Secondary	Maternal satisfaction with analgesia		At the end of the vaginal delivery (this time period underwent changing in different individuals)	No
Secondary	Maternal oral temperature		Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)	Yes
Secondary	Use of oxytocin after analgesia		Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)	Yes
Secondary	Maximal oxytocin dose		At the end of vaginal delivery (this time period underwent changing in different individuals)	No
Secondary	Breastfeeding success at 6 weeks after vaginal delivery		At the sixth week after successful delivery	Yes
Secondary	Neonatal one-minute Apgar scale		At the first minute of baby was born	Yes
Secondary	Neonatal five-minute Apgar scale		At the fifth minute of baby was born	Yes
Secondary	Umbilical-cord gases analysis		At the time baby was born (0 min)	Yes
Secondary	Neonatal sepsis evaluation		After the baby was born (15 min after delivery)	Yes
Secondary	Neonatal antibiotic treatment		After the baby was born (one day after delivery)	Yes
Secondary	Incidence of maternal side effects		Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals)	Yes