Recruiting

Terbutaline

Sponsor:

Kai Schoenhage

Code:

NCT01651962

Conditions

Labor Pain

Eligibility Criteria

Sex: Female

Age: 18 - 53

Healthy Volunteers: Not accepted

Interventions

Terbutaline

Fentanyl

0.9% NaCl

Study Details

Brief summary:

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.

Conditions

Labor Pain

Study ID

NCT01651962

Start date

Aug, 2012

Status verified date

Jan, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 53

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Terbutaline

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

active comparator: Fentanyl

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

placebo comparator: Placebo

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

Interventions

Terbutaline

Fentanyl

0.9% NaCl

Primary outcome measure

  • reduction of pain score on a visual analog scale (VAS) of 1-10 [ Time Frame: 0-30 minutes ]

Central Contacts and Locations

Central contacts

Kai Schoenhage, MD

(520) 626-7221kschoenhage@anesth.arizona.edu

Locations

Tucson Medical Center

Recruiting

Tucson, Arizona, United States, 85712

Principal Investigator:

Schoenhage Monique, M.D.

University of Arizona Medical Center

Recruiting

Tucson, Arizona, United States, 85724

Principal Investigator:

Kai Schoenhage, M.D.

More Information

Sponsor

Kai Schoenhage

Last update posted

Jan 19, 2015

Last verified

Jan, 2015

Keywords

  • Labor Pain
  • Analgesia, Epidural

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kai Schoenhage on 2015-01-19.