Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

Kai Schoenhage

Status and phase: Unknown; Phase 4

Conditions: Labor Pain

Treatments: Drug: Fentanyl; Drug: 0.9% NaCl; Drug: Terbutaline

Study type: Interventional

Funder types: Other

Identifiers

NCT01651962

12-0412

Details and patient eligibility

About

Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter.

Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal.

This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 53 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• in labor
• labor pain >3 on visual analog scale (VAS)

Exclusion criteria

• cardiovascular disease
• preeclampsia
• diabetes mel-litus
• thyroid disease
• current (outpatient) opioid medication
• recent and / or current use of cocaine
• seizure disorder
• psychiatric disease
• body mass index >35
• preterm labor (<37 weeks pregnant)
• known allergies to any of the three study substances

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 3 patient groups, including a placebo group

Terbutaline

Experimental group

Description:

Terbutaline 0.125mg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN

Treatment:

Drug: Terbutaline

Fentanyl

Active Comparator group

Description:

Fentanyl 100mcg i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN

Treatment:

Drug: Fentanyl

Placebo

Placebo Comparator group

Description:

0.9% NaCl i.v. x 1 dose prior to positioning for epidural placement; may repeat x1 PRN

Treatment:

Drug: 0.9% NaCl