N/A
Completed N=109
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion
Abortion in First Trimester
Source: ClinicalTrials.gov NCT03187002 ↗
Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Aspiration Pain — 73; 66 units on a scale
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.
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 | — |
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
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. Informational only — not medical advice.