Phase 4
N=24
Oral Sedation During Cervical Dilator Placement
Oral Sedation and Cervical Dilator Pain
Bottom Line
View on ClinicalTrials.gov: NCT03202550 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device — 55; 44 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxycodone and Lorazepam (Active Comparator) (Drug); Placebo Comparator (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins University
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device |
55; 44 | — |
| SECONDARY Number of Participants With Desired Number of Dilators Inserted |
13; 10 | — |
| SECONDARY Baseline Pain Score Before Drugs Were Administered |
3; 2 | — |
| SECONDARY Pain Score Before Speculum Placement |
1; 1 | — |
| SECONDARY Pain Score After Speculum Placement |
20; 11 | — |
| SECONDARY Pain Score at Tenaculum Placement |
31; 50 | — |
| SECONDARY Pain Score During Paracervical Block |
57; 51 | — |
| SECONDARY Pain Score After First Dilator Placement |
50; 9 | — |
| SECONDARY Pain Score 15 Minutes After Last Dilator Placed |
29; 13 | — |
Summary
This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on pain scores during cervical dilator placement prior to dilation and evacuation (D&E).
Eligibility Criteria
Inclusion Criteria
- Women aged 18-50 years
- English speaking
- With an intrauterine pregnancy (either viable or non-viable) between the gestational ages of 17w0d and 23w6d
- Have a support person present with participant
- Have a cell phone capable of text messaging (optional)
Exclusion Criteria
- Non-English-speaking
- Taking a daily benzodiazepine or opiate
- Have a known allergy or contraindication to NSAIDs, opiates, or benzodiazepines
Data sourced from ClinicalTrials.gov (NCT03202550). 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.