Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion

Stanford University

Status: Completed

Conditions: Abortion in First Trimester

Treatments: Device: Transcutaneous electrical nerve stimulation (TENS); Other: SHAM: Transcutaneous electrical nerve stimulation (TENS); Drug: Moderate IV Sedation; Other: SHAM: Moderate IV Sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT03187002

IRB-41589

Details and patient eligibility

About

High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.

Enrollment: 109 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presenting for surgical abortion
• Gestational age <12 weeks
• < 18 years of age
• Agrees to be randomized

Exclusion criteria

• Allergy to study medications (lidocaine, fentanyl, midazolam)
• > 18 years of age
• Fetal demise
• Pre-procedure use of misoprostol
• No means of transportation following procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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109 participants in 2 patient groups

Transcutaneous electrical nerve stimulation (TENS)

Experimental group

Description:

Transcutaneous electrical nerve stimulation (TENS)

Treatment:

Device: Transcutaneous electrical nerve stimulation (TENS)

Other: SHAM: Moderate IV Sedation

Moderate IV Sedation

Active Comparator group

Description:

Fentanyl, versed

Treatment:

Other: SHAM: Transcutaneous electrical nerve stimulation (TENS)

Drug: Moderate IV Sedation