Abortion, Anxiety, Pain
Conditions
Brief summary
This single center, double blind, randomized controlled trial will evaluate whether adding intravenous diphenhydramine to a standard moderate sedation regimen improves pain control during first trimester procedural abortion. Participants undergoing uterine aspiration at less than 13 weeks gestation will be randomized 1 to 1 to receive standard moderate sedation with midazolam and fentanyl plus either diphenhydramine 50 mg intravenously or matching placebo. The primary outcome is participant reported pain during uterine aspiration measured by a 100 mm Visual Analog Scale.
Detailed description
Surgical abortion is commonly associated with pain and anxiety despite use of local anesthesia and moderate sedation. This study will evaluate the efficacy of intravenous diphenhydramine as an adjunct to a standard moderate sedation regimen for participants undergoing first trimester procedural abortion. This is a single center, double blind, randomized, placebo controlled trial conducted at the University of Rochester Family Planning Clinic and Strong Memorial Hospital. Participants undergoing first trimester uterine aspiration at less than or equal to 13 weeks gestation will be randomized in a 1 to 1 ratio using a computer generated block randomization scheme to receive either intravenous diphenhydramine 50 mg or matching placebo, in addition to standard moderate sedation with midazolam and fentanyl. Participants, clinical staff, and outcome assessors will remain blinded to treatment assignment. Pain will be assessed using a 100 mm Visual Analog Scale at baseline, during speculum placement, paracervical block, cervical dilation, uterine aspiration, 10 minutes after the procedure, and 1 hour after the procedure. Sedation depth during uterine aspiration will be assessed using the Modified Observer's Assessment of Alertness Sedation scale. Additional outcomes include total sedative medication dose, time to readiness for discharge, and sedation related adverse events.
Interventions
DRUGDiphenhydramine
Diphenhydramine 50 mg administered intravenously once prior to the procedure.
DRUGPlacebo
Matching placebo composed of normal saline administered intravenously once prior to the procedure.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults age 18 years and older * Desire procedural abortion with moderate sedation * Gestational age less than or equal to 13 weeks * Intrauterine pregnancy or pregnancy of unknown location * Body mass index less than or equal to 40
Exclusion criteria
* Desire medical abortion or desire to continue pregnancy * Gestational age greater than 13 weeks * Body mass index greater than 40 * Age younger than 18 years * Confirmed ectopic pregnancy * Medical condition that is a contraindication to moderate sedation as determined by the treating clinician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant-Reported Pain During Uterine Aspiration | During the procedure, at the time of uterine aspiration | Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst pain imaginable." Higher scores indicate greater pain intensity. This outcome measures the participant's perceived pain during uterine aspiration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation Depth During Uterine Aspiration | During the procedure, at the time of uterine aspiration | Sedation depth will be assessed using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. The MOAA/S scale ranges from 0 to 5, where 5 indicates fully alert and 0 indicates no response to painful stimulus. Lower scores indicate deeper levels of sedation. This outcome measures the level of sedation achieved during uterine aspiration. |
| Participant-Reported Pain at Speculum Placement | During the procedure, at the time of speculum placement | Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS), where 0 represents "no pain" and 100 represents "worst pain imaginable." Higher scores indicate greater pain intensity. This outcome measures pain experienced during speculum placement. |
| Participant-Reported Pain at Paracervical Block | During the procedure, at the time of Paracervical Block | Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS), where 0 represents "no pain" and 100 represents "worst pain imaginable." Higher scores indicate greater pain intensity. This outcome measures pain experienced during administration of the paracervical block. |
| Participant-Reported Pain at Cervical Dilation | During the procedure, at the time of Cervical Dilation | Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS), where 0 represents "no pain" and 100 represents "worst pain imaginable." Higher scores indicate greater pain intensity. This outcome measures pain experienced during cervical dilation. |
| Participant-Reported Pain 10 Minutes After Procedure Completion | 10 minutes after completion of the procedure | Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS), where 0 represents "no pain" and 100 represents "worst pain imaginable." Higher scores indicate greater pain intensity. This outcome measures post-procedure pain at 10 minutes. |
| Participant-Reported Pain 1 Hour After Procedure Completion | 1 hour after completion of the procedure | Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS), where 0 represents "no pain" and 100 represents "worst pain imaginable." Higher scores indicate greater pain intensity. This outcome measures post-procedure pain at 1 hour. |
| Time to Readiness for Discharge | From completion of the procedure until discharge readiness, up to approximately 2 hours | Time from procedure completion to when the participant meets discharge criteria, measured in minutes. Higher values indicate longer recovery time. |
| Incidence of Sedation-Related Adverse Events | From administration of study medication through discharge on the day of procedure | Number and proportion of participants experiencing sedation-related adverse events, including hypoxia, hypotension, use of reversal agents (naloxone or flumazenil), paradoxical agitation, respiratory depression requiring supplemental oxygen beyond nasal cannula, hypotension requiring vasopressors, or unplanned hospital admission. Higher values indicate greater incidence of adverse events. |
Countries
United States
Contacts
CONTACTSarah Cavegila, MPH
Outcome results
None listed