Efficacy of Oral Nifedipine, Naproxen, or Placebo for Pain Relief During Diagnostic Hysteroscopy in an Office Setting: A Randomized Pilot Study

Steffi van Wessel; Julie Rombaut; Astrid Vanhulle; Mark Hans Emanuel; Tjalina Hamerlynck; Steven Weyers

doi:10.1016/j.jmig.2023.02.010

Efficacy of Oral Nifedipine, Naproxen, or Placebo for Pain Relief During Diagnostic Hysteroscopy in an Office Setting: A Randomized Pilot Study

J Minim Invasive Gynecol. 2023 Jun;30(6):473-479. doi: 10.1016/j.jmig.2023.02.010. Epub 2023 Feb 16.

Authors

Steffi van Wessel¹, Julie Rombaut², Astrid Vanhulle², Mark Hans Emanuel³, Tjalina Hamerlynck², Steven Weyers²

Affiliations

¹ Women's Clinic, Ghent University Hospital (Drs. Wessel, Rombaut, Vanhulle, Hamerklynck, Weyers), Ghent, Belgium. Electronic address: steffi.vanwessel@uzgent.be.
² Women's Clinic, Ghent University Hospital (Drs. Wessel, Rombaut, Vanhulle, Hamerklynck, Weyers), Ghent, Belgium.
³ Women's Care, Bergman Clinics (Dr. Emanuel), Hilversum, Netherlands; Department of Reproductive Medicine and Gynecology, University Medical Center (Dr. Emanuel), Utrecht, The Netherlands.

PMID: 36804576
DOI: 10.1016/j.jmig.2023.02.010

Abstract

Study objective: To compare nifedipine, naproxen, or placebo for pain relief during diagnostic hysteroscopy.

Design: Double-blind, randomized controlled pilot study.

Setting: University hospital.

Patients: Women scheduled for office diagnostic hysteroscopy (n = 60).

Interventions: Women received nifedipine (2 tablets of 10 mg), naproxen (2 tablets of 250 mg), or placebo (2 tablets of 500 mg lactose) 30 to 60 minutes prior to hysteroscopy.

Measurements and main results: Sixty patients were enrolled in the study (21 in the nifedipine group, 19 in the naproxen group, and 20 in the placebo group). The median pain scores during hysteroscope insertion, measured on a Visual Analog Scale (VAS), were 1 (interquartile range (IQR) 0-0), 2 (0-4) and 1 (0-1) in the nifedipine, naproxen and placebo group, respectively (P,14). The median VAS scores during hysteroscopy were 5 (IQR 2-7), 5 (4-8) and 5 (3-7) in the nifedipine, naproxen and placebo group, respectively (P,73). The median VAS scores immediately after hysteroscopy were 2 (IQR 0-4), 3 (0-6) and 3 (1-5) in the nifedipine, naproxen and placebo group, respectively (P,40). The median VAS scores 30 minutes after hysteroscopy were 1 (IQR 0-2), 1 (0-1) and 1 (0-2) in the nifedipine, naproxen and placebo group, respectively (P,63). Hysteroscope insertion failed in 1 case (naproxen group) because of cervica`l stenosis (P,32). Flushes, fatigue and vertigo, 30 minutes after the procedure, were significantly more prevalent in the nifedipine group compared to the naproxen (p < .001, p,03, p,03, respectively) and the placebo group (p < .001, p,01, p,01, respectively). Palpitations occurred only in the nifedipine group (p < .001). The day after the procedure, the headache was most prevalent in the nifedipine group compared to the naproxen group (p,001) and the placebo group (p,001).

Conclusion: In our pilot study, pain relief and success rates for office diagnostic hysteroscopy were not significantly different between nifedipine, naproxen, and placebo. Nifedipine was associated with more, albeit tolerable, side-effects.

Keywords: Diagnostic hysteroscopy; Efficacy; Naproxen; Nifedipine; Office hysteroscopy; Pain relief.

Publication types

Randomized Controlled Trial

MeSH terms

Double-Blind Method
Female
Humans
Hysteroscopy* / methods
Naproxen* / therapeutic use
Nifedipine / therapeutic use
Pain / etiology
Pilot Projects
Pregnancy

Substances

Naproxen
Nifedipine