Effectiveness Not Established

Ativan, Bendryl, and Haldol Gel (ABH Gel)

for Chemotherapy-Induced Nausea and Vomiting—Adult

A topical gel made from a combination of lorazepam (Ativan®), diphenhydramine (Benadryl®), and haloperidol (Haldol®) that is typically applied to the volar surface of the wrist. It has been studied in the treatment of nausea and vomiting related to chemotherapy. 

Research Evidence Summaries

Fletcher, D.S., Coyne, P.J., Dodson, P.W., Parker, G.G., Wan, W., & Smith, T.J. (2014). A randomized trial of the effectiveness of topical "ABH Gel" (Ativan®, Benadryl®, Haldol®) versus placebo in cancer patients with nausea. Journal of Pain and Symptom Management, 48(5), 797–803.

Study Purpose

To determine the effectiveness of ABH gel (containing Ativan®, Benadryl®, and Haldol®) on chemotherapy-induced nausea and vomiting (CINV) in patients with cancer

Intervention Characteristics/Basic Study Process

The ABH gel or “cocktail” was prepared by the investigational pharmacy in 10 ml gel form (consisting of lorazepam 20 mg, Benadryl® 250 mg, Haldol® 20 mg, lecithin organogel 2 ml, ethoxydiglycol 0.83 ml, water 0.2 ml, and pluronic gel 20%). This gel-form cocktail yielded 10 doses of 1.0 ml with each application to be dispensed in individual syringes. A placebo gel was prepared using an inactive pluronic lecithin organogel alone.
 
The study participants were instructed to place their designated 1.0 ml of the study gel on the palmar aspect of their wrists using a prefilled syringe, and to rub their wrists together for two minutes. Nausea scores were recorded before the gel was applied and then at 30, 60, 90, 120, 180, and 240 minutes after the gel was applied. If the first ABH gel treatment was ineffective, the patients were asked to apply a second gel treatment. After two hours, if the second gel treatment also failed or for uncontrolled nausea, the researchers used the traditional pharmacological treatment.

Sample Characteristics

  • N = 22  
  • MEAN AGE = 47.1 years (range = 18–72 years)
  • MALES: 6 (27.3%), FEMALES: 16 (72.7%)
  • KEY DISEASE CHARACTERISTICS: The majority of the enrolled patients were status post–bone marrow transplant and other types of cancer, but the types of cancer were not specified.  
  • OTHER KEY SAMPLE CHARACTERISTICS: Twenty patients had Hispanic or Latino background, 16 patients were Caucasian, and six were African American.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Multi-site  
  • LOCATION: An outpatient bone marrow transplant clinic and an inpatient palliative care unit at the Virginia Commonwealth University Massey Cancer Center in Richmond, United States

Phase of Care and Clinical Applications

  • APPLICATIONS: Palliative care

Study Design

A randomized, double-blind, placebo-controlled, crossover, noninferiority clinical trail

Measurement Instruments/Methods

  • The Condensed Memorial Symptom Assessment Scale (CMSAS) was used to assess the symptoms of nausea.

Results

In total, 22 patients enrolled in the study. However, 20 patients completed both arms (treatment and placebo) as a crossover. In the results section, the researcher listed three important findings: the mean change in the nausea score from baseline to 60 minutes post-treatment in both groups was not statistically significant; the ABH gel was not topically absorbed well even four hours after application; and almost 67% of the study patients stated that treatment was not effective in relieving symptoms.

Conclusions

The researchers concluded that the ABH gel in its current formulation should not be used for patients with cancer.

Limitations

  • Small sample (< 30)

 

Nursing Implications

The same authors also demonstrated similar results in healthy volunteers in their previously published study in the May 2012 issue of the same journal titled “ABH Gel is not Absorbed From the Skin of Normal Volunteers,” which found that ABH gel is not absorbed well topically. In that study, lorazepam and Haldol® were almost undetectable in the blood samples of healthy study subjects; in other words, the plasma samples indicated that ABH gel was clinically or therapeutically insignificant. Therefore, ABH gel in its current formulation should not be used in patients with cancer.

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