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A randomized controlled trial of nitrous oxide for intrauterine device insertion in nulliparous women
Author(s) -
Singh Rameet H.,
Thaxton Lauren,
Carr Shan,
Leeman Lawrence,
Schneider Emily,
Espey Eve
Publication year - 2016
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2016.04.014
Subject(s) - medicine , randomized controlled trial , anesthesia , nitrous oxide , randomization , adverse effect , inhalation , visual analogue scale , surgery , obstetrics
Objective To evaluate the effectiveness of inhaled nitrous oxide for pain management among nulliparous women undergoing intrauterine device (IUD) insertion. Methods A double‐blind, randomized controlled trial was conducted among nulliparous women aged 13–45 years who underwent IUD insertion at a US center between October 1, 2013, and August 31, 2014. Using a computer‐generated randomization sequence, participants were randomly assigned to inhale either oxygen (O 2 ) or a mixture of 50% nitrous oxide and 50% oxygen (N 2 O/O 2 ) through a nasal mask for 2 minutes before insertion. Only the person administering the inhalation agent was aware of group assignment. The primary outcome was maximum pain assessed 2 minutes after insertion via a 100‐mm visual analog scale. Analyses were by intention to treat. Results Forty women were assigned to each group. Mean maximum pain score at the time of insertion was 54.3 ± 24.8 mm for the N 2 O/O 2 group and 55.3 ± 20.9 mm for the O 2 group ( P = 0.86). Adverse effects were reported for 6 (15%) women in the N 2 O/O 2 group and 7 (18%) in the O 2 group ( P = 0.32). Conclusion N 2 O/O 2 did not reduce the pain of IUD insertion among nulliparous women. ClinicalTrials.gov: NCT02391714