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Phase 4 Completed N=70 Randomized Treatment

Overnight Pain Treatment Investigating Opioids vs. Nonopioids

Abortion Second Trimester
Source: ClinicalTrials.gov NCT03545893 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Maximum Pain Score — 4.66; 6.51 score on a scale
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The purpose of this study is to compare maximum pain scores between patients seeking induced abortion and requiring cervical preparation with osmotic dilators. Patients will be randomized to receive prescription for ibuprofen alone or to receive prescription for ibuprofen + oxycodone for overnight pain management after cervical preparation with osmotic dilators. Data collected in-person and through a text-messaging platform.

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Pain Score
4.66; 6.51

Eligibility Criteria

Inclusion Criteria

  • English-speaking women
  • 18 years or older
  • Access to cell phone with text-messaging capability/data
  • Receiving cervical preparation for induced abortion
  • Able to complete baseline survey on smartphone/tablet at screening visit

Exclusion Criteria

  • History of opioid or alcohol abuse
  • Contraindications or allergy to ibuprofen
  • Contraindications or allergy opioid medications
  • Seeking uterine evacuation for premature preterm rupture of membranes or advanced - cervical dilation or intrauterine fetal demise
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03545893). 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.

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