About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Diphenhydramine
Drug
Diphenhydramine 50 mg administered intravenously once prior to the procedure.
Placebo
Drug
Matching placebo composed of normal saline administered intravenously once prior to the procedure.

Treatment groups

98 Participants

are divided into 2 treatment groups

Group A: Diphenhydramine plus standard moderate sedationExperimental treatment 1 intervention

Group B: Placebo plus standard moderate sedationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Participant-Reported Pain During 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.

Time frame

During the procedure, at the time of uterine aspiration

Secondary outcomes

1

Sedation Depth During 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.

Time frame

During the procedure, at the time of uterine aspiration

2

Participant-Reported Pain at 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.

Time frame

During the procedure, at the time of speculum placement

3

Participant-Reported Pain at 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.

Time frame

During the procedure, at the time of Paracervical Block

4

Participant-Reported Pain at 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.

Time frame

During the procedure, at the time of Cervical Dilation

Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts