A Randomized Trial of the Effectiveness of Topical "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) Versus Placebo in Patients With Nausea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.
研究概览
简要总结
This randomized clinical trial studies ABH (lorazepam, diphenhydramine hydrochloride, and haloperidol) gel in patients with nausea. ABH gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting. The general purpose of this research study is to improve the treatment of nausea and vomiting.
详细描述
PRIMARY OBJECTIVES:
I. The primary outcome is the change in numeric rating scale in self-reported nausea on a 0-10 scale from baseline to 60 minutes of treatment.
OUTLINE: All individuals who are eligible are randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. The randomization list will be generated by the Study Biostatistician. Neither the patient nor the investigator will have knowledge of the actual content of Drug A or B, so the study will be double-blinded, and placebo controlled.
Drug A: The dose of the drugs in the 1.0 mL dose will be 2 mg of lorazepam, 25 mg of diphenhydramine, and 2 mg of haloperidol in a pluronic lecithin organogel. It will be rubbed on the volar surface of the wrists by the subject, for 2 minutes as done in clinical practice, at time 0. Drug B: equivalent but no ABH.
Subjects will rub 1 mL of the first drug, Drug A gel, between their wrists for 2 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •No allergies to the drugs
- •Able to complete the forms
- •If a woman of childbearing age, agree to use contraception; women will be offered a pregnancy test before doing the trial if they request one, as stated in the Informed Consent Form
- •Patients must have a self reported nausea score of at least 4 on a numeric rating scale of 0-10 (zero being no nausea and ten being the worst possible nausea); patients are not required to have vomiting
- •Patients must have had or have cancer, or have had a consultation with the palliative care team
- •They must not have had any changes to their nausea program within the past 12 hours, if on anti-emetics
- •Patients must not have received chemotherapy within 5 days, unless it is a stable oral chemotherapy drug such as capecitabine (Xeloda), erlotinib (Tarceva), or similar
排除标准
- •History of substance abuse, psychiatric disorder, acquired brain injury, the possibility of pregnancy (not using birth control, and of child bearing age)
- •Use of any medication that would contraindicate benzodiazepine administration
- •Pregnant or nursing
研究组 & 干预措施
Placebo then ABH
All subjects randomized to two sequences of treatments: either placebo-ABH or ABH-placebo. All participants will receive both drug A and drug B.
After applying gel, Drug A or B, on wrists for 2 minutes, time 0. From baseline to 60 minutes of treatment two options will occur. At 60 minutes, if patients have at least 1 point reduction in their nausea score, they must wait 4 hours before switching to opposite drug. After administration of drug, the study procedures will be repeated. Or, at 60 minutes, if no change or increase in nausea score has been recorded, alternative treatment will be given. If the second treatment is ineffective at one hour (total time 2 hours) then alternative usual medications will be given. After completion of study treatment, patients are followed up for up to 8 hours.
干预措施: ABH gel (Drug)
Placebo then ABH
All subjects randomized to two sequences of treatments: either placebo-ABH or ABH-placebo. All participants will receive both drug A and drug B.
After applying gel, Drug A or B, on wrists for 2 minutes, time 0. From baseline to 60 minutes of treatment two options will occur. At 60 minutes, if patients have at least 1 point reduction in their nausea score, they must wait 4 hours before switching to opposite drug. After administration of drug, the study procedures will be repeated. Or, at 60 minutes, if no change or increase in nausea score has been recorded, alternative treatment will be given. If the second treatment is ineffective at one hour (total time 2 hours) then alternative usual medications will be given. After completion of study treatment, patients are followed up for up to 8 hours.
干预措施: placebo (Other)
ABH then placebo
All subjects randomized to two sequences of treatments: either placebo-ABH or ABH-placebo. All participants will receive both drug A and drug B.
After applying gel, Drug A or B, on wrists for 2 minutes, time 0. From baseline to 60 minutes of treatment two options will occur. At 60 minutes, if patients have at least 1 point reduction in their nausea score, they must wait 4 hours before switching to opposite drug. After administration of drug, the study procedures will be repeated. Or, at 60 minutes, if no change or increase in nausea score has been recorded, alternative treatment will be given. If the second treatment is ineffective at one hour (total time 2 hours) then alternative usual medications will be given. After completion of study treatment, patients are followed up for up to 8 hours.
干预措施: ABH gel (Drug)
ABH then placebo
All subjects randomized to two sequences of treatments: either placebo-ABH or ABH-placebo. All participants will receive both drug A and drug B.
After applying gel, Drug A or B, on wrists for 2 minutes, time 0. From baseline to 60 minutes of treatment two options will occur. At 60 minutes, if patients have at least 1 point reduction in their nausea score, they must wait 4 hours before switching to opposite drug. After administration of drug, the study procedures will be repeated. Or, at 60 minutes, if no change or increase in nausea score has been recorded, alternative treatment will be given. If the second treatment is ineffective at one hour (total time 2 hours) then alternative usual medications will be given. After completion of study treatment, patients are followed up for up to 8 hours.
干预措施: placebo (Other)
结局指标
主要结局
The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.
时间窗: 60 minutes after application
The outcome measure for change was calculated from value at baseline minus value at 60 minutes. Subjects were asked to rate their nausea on a 0 (no nausea) to 10 (worst possible nausea) scale. Subjects who were eligible were randomly assigned to two sequences: one sequence used ABH gel first and then placebo; and the other sequence used placebo first and then ABH gel. We assumed that there was no carry-over effect from the first treatment to the second. A paired t-test was used to compare if ABH gel is not better than the placebo gel. A repeated measure analysis was used to compare the two treatment sequences. This endpoint was chosen as the drug gel because it is typically used as a "prn" (as needed) gel in actual practice, when relief is needed in short order.
次要结局
未报告次要终点