Diphenhydramine as an Adjunct to Moderate Sedation for Procedural First Trimester Abortions
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Diphenhydramine, Placebo.
- Кому может быть актуально
- Состояния в реестре: Pain, Abortion, Anxiety. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Diphenhydramine
Diphenhydramine 50 mg administered intravenously once prior to the procedure. - Препарат Placebo
Matching placebo composed of normal saline administered intravenously once prior to the procedure.
Первичные конечные точки
- Participant-Reported Pain During Uterine Aspiration [Срок оценки: During the procedure, at the time of uterine aspiration]
Вторичные конечные точки (8)
- Sedation Depth During Uterine Aspiration [Срок оценки: During the procedure, at the time of uterine aspiration]
- Participant-Reported Pain at Speculum Placement [Срок оценки: During the procedure, at the time of speculum placement]
- Participant-Reported Pain at Paracervical Block [Срок оценки: During the procedure, at the time of Paracervical Block]
- Participant-Reported Pain at Cervical Dilation [Срок оценки: During the procedure, at the time of Cervical Dilation]
- Participant-Reported Pain 10 Minutes After Procedure Completion [Срок оценки: 10 minutes after completion of the procedure]
- Participant-Reported Pain 1 Hour After Procedure Completion [Срок оценки: 1 hour after completion of the procedure]
- Time to Readiness for Discharge [Срок оценки: From completion of the procedure until discharge readiness, up to approximately 2 hours]
- Incidence of Sedation-Related Adverse Events [Срок оценки: From administration of study medication through discharge on the day of procedure]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07542730 · STUDY00011436