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N/A N=140 Randomized Double-blind

Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

Abortion in First Trimester

Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Visual Analog Pain Score for Mean Maximum Procedural Pain — 54.37; 60.48 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Nitrous oxide administration (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
University of New Mexico
Primary completion
Apr 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Analog Pain Score for Mean Maximum Procedural Pain
54.37; 60.48
SECONDARY
Visual Analog Scale Score for Baseline Pain
4.7426; 4.4388
SECONDARY
Visual Analog Scale for Post-procedure Pain
26.68; 25.96
SECONDARY
Pain Management Satisfaction
69.3382; 61.5373
SECONDARY
Visual Analog Scale to Measure Anticipated Pain.
56.1544; 50.3104

Summary

The purpose of this research is to study the effect of nitrous oxide on pain felt by women having a surgical termination at less than 11 weeks compared to pain felt by women receiving oral pain medications.

Eligibility Criteria

Inclusion Criteria

  • 18 years old or older,
  • elective pregnancy termination at gestational age of less than 11 weeks,
  • speak English
  • candidate for an in-clinic procedure.
  • desire local anesthesia, ibuprofen, Vicodin and Ativan (the usual treatment in our clinic) for managing pain

Exclusion Criteria

  • no medical problems preventing the use of nitrous oxide
  • no allergies to nitrous oxide, lidocaine, vasopressin, ibuprofen, Vicodin or Ativan
  • significant active upper respiratory infection
  • chronic obstructive pulmonary disease (COPD)
  • intoxication
  • use of street drugs
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02096575). 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.

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