N/A N=109 Randomized Triple-blind Treatment

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

Abortion in First Trimester

Bottom Line

View on ClinicalTrials.gov: NCT03187002 ↗

Enrolled (actual)

109

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: Aspiration Pain — 73; 66 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcutaneous electrical nerve stimulation (TENS) (Device); Moderate IV Sedation (Drug); SHAM: Transcutaneous electrical nerve stimulation (TENS) (Other); SHAM: Moderate IV Sedation (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Stanford University
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Aspiration Pain	73; 66	—
SECONDARY Speculum Placement Pain	27; 17.5	—
SECONDARY Tenaculum Placement Pain	34.5; 23.5	—
SECONDARY Paracervical Block Pain	48.5; 34.5	—
SECONDARY Manual Cervical Dilation Pain	67; 56	—
SECONDARY Speculum Removal Pain	38.5; 23	—
SECONDARY Total Procedure Time	7; 6.4	—

Summary

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.

Eligibility Criteria

Inclusion criteria

Presenting for surgical abortion
Gestational age 18 years of age
Fetal demise
Pre-procedure use of misoprostol
No means of transportation following procedure

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Data sourced from ClinicalTrials.gov (NCT03187002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.