39

Journal of Vestibular Research 24 (2014) 3947

DOI 10.3233/VES-140506
IOS Press

Intravenous promethazine versus lorazepam

for the treatment of peripheral vertigo in the
emergency department: A double blind,
randomized clinical trial of efficacy and safety
Afshin Aminia , Kamran Heidarib , Shadi Asadollahic,, Tahereh Habibia , Ali Shahramia ,
Behnam Mansourid and Hamidreza Karimana
a

Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences,
Tehran, Iran
b
Department of Emergency Medicine, Shohadaye-Haftom Tir Hospital, Shahid Beheshti University of Medical
Sciences, Tehran, Iran
c
School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
d
Department of Neurology, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Abstract.
BACKGROUND: Vertigo imposes considerable health restrictions with significant impact on the patients quality of life. The
most effective antivertigo agent is undetermined thus far.
OBJECTIVE: This study was performed to assess whether promethazine has superior vertigo reduction compared with lorazepam in ED patients.
METHODS: In this randomized, double-blind, parallel group trial 184 patients were assigned (1:1 ratio) to receive either promethazine, 25 mg intravenously, or lorazepam, 2 mg intravenously. Primary endpoint was mean change in vertigo intensity at 2 hours
measured using visual analog scale (VAS). Secondary endpoints were mean change in nausea score, need for second dose of
study medications, and adverse events (AEs).
RESULTS: Promethazine was associated with significantly more reduction (46.5 mm) in vertigo than lorazepam (25.7 mm,
p < 0.001). Mean change in nausea score 2 hours after drug injection on the VAS was 28.7 mm for promethazine and 22.8 for
lorazepam (p = 0.002). The most frequently reported AEs were lethargy (14.1% in lorazepam group, 4.3% in promethazine
group, p = 0.013) and drowsiness (10.8% for promethazine, 2.1% for lorazepam, p = 0.017).
CONCLUSION: Our study demonstrated the evidence that promethazine is superior to lorazepam in management of peripheral
vertigo and vertigo-related nausea in ED adults.
Keywords: Vertigo, nausea, promethazine, lorazepam, clinical trial

1. Introduction
Vertigo is a common reason for seeking initial medical evaluation and care in the emergency department
Corresponding author: Shadi Asadollahi, School of Medicine,
Shahid Beheshti University of Medical Sciences, Daneshju Blvd,
Evin, Tehran, Iran. Tel.: +98 912 770 91 49; Fax: +98 21 552 037
97; E-mail: asadollahi.shadi@yahoo.com; shasadollahi@sbmu.ac.ir.

(ED) [1]. This disorder imposes substantial health restrictions with significant impact on the patients quality of life; in unresolved patients, it may lead to immobilization or chronic invalidism [2]. Therefore, the
availability of an efficient antivertigo therapy would be
of considerable significance, both for individual care
and pharmacoeconomic purposes [3].
The management of patients suffering from peripheral vertigo is rather controversial, since the patho-

c 2014 IOS Press and the authors. All rights reserved

ISSN 0957-4271/14/$27.50 

40

A. Amini et al. / Intravenous promethazine versus lorazepam for the treatment of peripheral vertigo

physiology is often indefinite. Various pharmacological agents have been found to exert antivertiginous activity. An ideal treatment should have rapid onset of action and lack debilitating adverse effects [4]. However,
there is a considerable lack of therapeutic information
and clinical trials focusing on emergency treatment of
peripheral vertigo [5].
The emergency standard care for patients presenting
with vertigo is excluding serious medical etiologies according to medical history, physical examination, and
diagnostic evaluation [6]. Commonly after exclusion
of central etiology, patients are treated with a broad
range of pharmacological modalities with variable efficacy [4]. Pharmacologic agents to control vertigo are
efficient in 6080% of cases [7].
Several medications from different pharmacologic
groups have been employed for this purpose, including antihistamines, anticholinergics, benzodiazepines,
calcium channel blockers, diuretics, neuroleptics, psychotherapeutic agents, and corticosteroids [811].
Therefore, we designed this trial to compare the efficacy of a phenothiazine and a benzodiazepine drug for
the treatment of vertigo in the ED because both classes
of drugs are commonly used in emergency setting [12
15].
Promethazine, a component of phenothiazine drugs,
acts as an antiemetic agent with dopamine, histamine
(H1) and muscarinic receptor antagonist activity [16].
Whereas, lorazepam is a benzodiazepine producing
gamma-aminobutyric acid modulation, and central
suppression of vestibular responses [17,18]. Benzodiazepines are useful medications for management of
vertigo in small dosage administration. Lorazepam is
an advantageous medication due to its effectiveness
and simple kinetic properties without active metabolite [19].
In the current study, we compared the efficacy and
safety of 25 mg of intravenous (IV) promethazine versus 2 mg of intravenous lorazepam for the treatment of
peripheral vertigo in ED. To the best of our knowledge,
this is the first interventional study in which these medications are compared. This aim of this study was to
provide a medical evidence to evaluate the use of phenothiazines in the treatment of peripheral vertigo.

2. Methods
2.1. Study design
This randomized, double-blind, and parallel group
trial was conducted in accordance with Good Clinical

Practices Guidelines [20], Declaration of Helsinki [21],

and was approved by the Institutional Review Board.
The trial has been registered with http://www.clinica
ltrials.gov (registration number, NCT01827293). A
written informed consent was obtained from each potential participant.
2.2. Study setting and population
The study was performed at a university-affiliated
teaching hospital ED. This center evaluates approximately 65,000 patients annually. It has an extensive array of residency and fellowship training programs. The
ED is staffed by board-certified attending physicians
and residents in emergency medicine, otorhinolaryngology and other specialties.
A consecutive sample of adult patients presenting
to the ED with signs and symptoms consistent with
peripheral vertigo were eligible for inclusion. Eligible participants were screened and enrolled at triage or
through clinical consultation by the emergency physicians and otorhinolaryngologists. The enrollment was
performed 24 hours per day and 7 days per week. Inclusion and exclusion criteria are shown in Table 1.
2.3. Study protocol
A structured data form was completed to record data
including demographics, onset and duration of symptoms, associated symptoms (nausea, vomiting, tinnitus,
and headache), change in hearing, neurotological history, current medications use, history of recent otitis,
head trauma, and vertigo and the specific diagnosis.
All participants underwent a physical examination
(neurological and neurotological) and a complete bedside vestibular test, including Dix-Hallpike maneuver,
Rinne and Weber test, oculomotor examination, positional test, head thrust test, Rombergs test, tandem
gait test, and Fukuda stepping test. The primary physical examination was performed by the study otorhinolaryngologists.
Eligible patients were randomly assigned (1:1 ratio), according to a computer-generated random number schedule, to receive IV promethazine (25 mg/mL)
or IV lorazepam (2 mg/mL). The randomization was
implemented by the study coordinator.
The trial medications were provided in consecutively numbered packs in Pharmacy Department of
the hospital. The Pharmacy supplied identical syringes
containing either 2 mg of lorazepam or 25 mg of
promethazine. They were diluted in 1 mL of normal

A. Amini et al. / Intravenous promethazine versus lorazepam for the treatment of peripheral vertigo

41

Table 1
Inclusion and exclusion criteria of screened patients
Inclusion criteria:

Aged 18 years or older (< 65 years)

Complaining of vertigoa

Exclusion criteria:

Unable to provide informed consent

Pregnant or possibly pregnant
Known allergy to study medications
Use of antiemetic agents in the previous 24 hours
Evidence of drug-induced vertigo or orthostatic hypotension
Traumatic brain injury
Central origin for vertigob

a Defined

as a sensation of motion either of self or of the surroundings associated with changes in head position. b Associated with neurologic
symptoms such as headaches, aura, visual, sensory or motor symptoms (diplopia, dysarthria, aphasia, weakness, and sensation abnormalities) and
signs of a cerebellar dysfunction such as dysmetria on finger-to-nose testing and dysdiadochokinesi, loss of balance and difficulty maintaining
posture, standing, and walking.

saline solution. There was no direct communication

between the pharmacist and the enrolling physicians,
nurses, and outcome assessors. Thus, the blinded design appeared to be completely successful. The randomization code remained intact until data entry and
analysis had been completed. Two sealed packs were
used for each patient and contained a data collection
from and one opaque syringe of promethazine or lorazepam. The study packs were stored in a safe site
with restricted access in the ED.
A solution of Ringers lactate was given intravenously for each patient at a rate of 100 mL/h using
volumetric infusion pump to compensate for possible
blood volume loss due to nausea and vomiting.
Treatment group 1 received 25 mg of IV promethazine, and treatment group 2 received 2 mg of IV
lorazepam. The medication doses were similar to the
standard doses routinely used in our ED. Nurses were
instructed to administer the medications slowly intravenously. The treating physicians, nurses, and patients
were blinded to which medication was being administrated.
2.4. Measurements
Prior to treatment, participants ranked their baseline
vertigo on a horizontal visual analog scale (VAS) of
100 mm in length. The left endpoint of the scale was 0
= no vertigo and the right endpoint was 10 = worst
possible vertigo. We determined the efficacy of each
drug based on the ultimate resolution of vertigo after
treating the first symptom. Another VAS of 100 mm
in length was used to record post-intervention score at
2 hours after administration of the drugs. The enrolling
physicians instructed each patient to mark a single
number on the scale corresponding to the level of vertigo sensation. Therefore, the patients were evaluated

and recorded their pre- and post-intervention level of

vertigo on a VAS under supervision of treating physicians.
The primary efficacy outcome was the mean change
in vertigo intensity score between pre-and post-intervention at 2 hours postdose. Secondary outcomes included, mean change in nausea VAS score, need for
second dose of study medications, and the rate of drugrelated adverse events (AEs) for the subjects in each
study group after intervention. Differences in mean
level of nausea were measured using VAS (no nausea at 0 mm, and maximum possible nausea at
100 mm). Nausea was evaluated prior to intervention
and at 2 hours after drug administration.
All AEs occurring during the study period and observed by the treating physicians, or reported by the
patients, were noted on the appropriate form. If the patients vertigo did not improved or the symptoms recurred, the patient received the second dose of previously administered medication. Recurrence was defined as a redevelopment of symptoms subsequent to
complete resolution of the vertigo.
The enrolling otorhinolaryngologists could decide
to discharge the patient 8 hours after intervention, continue treatment, or perform further diagnostic evaluation while remaining blinded to the study intervention. If the patient still had not recovered adequately
to walk without assistance or continued to vomit, additional management, consultation, or admission was
performed at the discretion of the treating otorhinolaryngologists. The patients with diagnosis of benign
paroxysmal positional vertigo (BPPV) were not treated
with repositioning maneuvers until after the final outcome measurement.
2.5. Data analysis
Initial sample size calculation indicated that 128 patients (64 per group) were needed to detect a difference

42

A. Amini et al. / Intravenous promethazine versus lorazepam for the treatment of peripheral vertigo

of two points or more on the vertigo scale, based on

a two-tailed alpha of 0.05 and a standard deviation of
four. Assuming that 40% of patients could not finish
the trial, 220 subjects were needed.
Comparisons of continuous variable between groups
were performed by two-sample t-test or WilcoxonMann-Whitney test whenever appropriate. Categorical
variables were compared by means of the Chi-square
test or the Fishers exact test. Statistical analyses were
performed using the Statistical Package for the Social
Sciences, version 21.0 for Windows (SPSS, Chicago,
Ill., USA). A significant level of 0.05 was used for all
analysis.

3. Results
Between April 4 and June 11, 2013, a total of 220
consecutive patients were enrolled in the study. Ten
patients refused to participate, and 26 patients were
excluded before randomization. Finally, 184 patients
were randomly assigned to receive either promethazine
(n = 92) or lorazepam (n = 92). The Consolidated
Standards of Reporting Trials (CONSORT) flow diagram is demonstrated in Fig. 1.
The patients ranged between 19 and 63 years of age,
with an average of 55 years. There were 86% patients
with BPPV, 8% with vestibular neuritis and 6% with
Mnires disease. The two treatment groups were similar with respect to demographics and baseline clinical
characteristics (Table 2).
3.1. Efficacy
The results of the primary and secondary outcome
variables are provided in Table 3. Subjects had similar
baseline vertigo VAS score (promethazine 73.0 mm,
lorazepam 69.3 mm) as well as nausea VAS score.
The majority of patients achieved the goal of a least
50% decrease in vertigo intensity index. Subjects in
the promethazine group exhibited a greater overall improvement in the vertigo intensity compared with those
in the lorazepam group. The mean decrease in the vertigo intensity in the promethazine group was 46.5 mm
compared with 25.7 mm in the lorazepam group (p <
0.001). The reference points used for this calculation
were time zero and the final time for which a vertigo
score was recorded at 2 hours postdose.
There was a significantly greater decrease in nausea score after 2 hours, among subjects in the promethazine arm (mean SD, 28.7 13.8) compared with

subjects in the lorazepam arm (mean SD, 22.8

12.1, p = 0.002).
With respect to proportion of patients receiving second dose of each study medication, greater proportion
of lorazepam-treated patients (27/92) required readministration compared with the promethazine-treated
group (9/92, p = 0.001). There was no difference in
the amount of fluid received by the two groups.
3.2. Safety
The safety analysis included all participants assigned to both study medications (n = 184). A total of
40 patients (21.7%) reported at least one AE during the
study: 19 patients (20.6%) in the promethazine group
and 21 patients (22.8%) in the lorazepam group. There
was no difference between treatment groups with respect to the AEs evaluation (p = 0.721).
The most frequently reported events were lethargy
(13 [14.1%] in the lorazepam group, 4 [4.3%] in the
promethazine group, p = 0.013) and drowsiness (10
patients [10.8%] for promethazine, 2 patients [2.1%]
for lorazepam, p = 0.017). These AEs resolved without treatment in ED. Lethargy as an abnormal state of
consciousness consisted of severe drowsiness in which
the patient could be aroused by moderate stimuli and
then drifted back to sleep. In addition, drowsiness was
defined as an extremely sleepy state.
Three patients in the promethazine treatment group
were noted to have an asymptomatic decrease in blood
pressure that did not require vasopressor therapy. Six
patients in the lorazepam group experienced apnea
and bradypnea resolving with bag-valve-mask ventilation. Two patients in the promethazine group experienced extrapyramidal symptoms (EPS) responding to
IV diphenhydramine therapy.

4. Discussion
Vertigo is a common complaint in the emergency
setting with debilitating influence that interrupts daily
activities and increases medical consultation [22].
Many pharmacological agents appeared to be clinically
useful in alleviating symptoms [4]. However, inadequate investigation has been performed in the ED setting to find the most effective antivertigo medication
with the fewest adverse effects [23]. We conducted a
randomized, double-blind trial comparing two intravenously administered medications commonly used in
the EDs: promethazine and lorazepam. The primary ef-

A. Amini et al. / Intravenous promethazine versus lorazepam for the treatment of peripheral vertigo

43

Fig. 1. The Consolidated Standards of Reporting Trials (CONSORT) patient flow diagram.

ficacy outcome measure; the patients sensation of vertigo with ambulation reduced more after promethazine
administration and the intensity of nausea, as well.
However promethazine was associated with greater
drowsiness compared to lorazepam. To our knowledge,
no published articles were found regarding ED patients
receiving promethazine to treat vertigo.
Several categories of antivertigo medications are
in common use for vertigo management. The main
groups of vestibular suppressants include antihistamines, benzodiazepines, and anticholinergics. Although

the exact mechanism of their therapeutic action is uncertain, most appeared to influence on the level of
neurotransmitters involved in transmission of impulses
through vestibular neurons and in maintenance of tone
in the vestibular nuclei [24].
Few randomized controlled trials have been conducted on the symptomatic treatment of acute vertigo. In 2000, Marill et al. [25] reported a randomized, double-blind clinical trial to reveal whether lorazepam (2 mg) was more effective than dimenhydrinate (50 mg) in reducing the symptoms of vertigo

44

A. Amini et al. / Intravenous promethazine versus lorazepam for the treatment of peripheral vertigo
Table 2
Demographic and baseline clinical characteristics of the study population
Characteristic
Age (mean SD)
Gender
Female
Duration of vertigo, hr
Mean (SD)
Median (range)
Vertigo history
Otitis history
Hypoacousia
Head trauma history
Family history of vertigo
Vomiting at presentation to ED
Etiology of vertigo
BPPV
Vestibular neuritis
Mnires disease

Promethazine
N = 92
55.8 13.8

Lorazepam
N = 92
53.7 17.3

p value
0.371

67 (72.8)

64 (69.5)

0.625

5.5 (2.5)
5 (213)
43 (46.7)
21 (22.8)
5 (5.4)
0 (0)
28 (30.4)
27 (29.3)

6.0 (2.8)
6 (217)
49 (53.2)
15 (16.3)
7 (7.6)
3 (3.2)
39 (42.4)
18 (19.5)

0.249

82 (89.1)
6 (6.5)
4 (4.3)

76 (82.6)
9 (9.8)
7 (7.6)

0.204
0.419
0.351

0.376
0.265
0.550
0.081
0.092
0.123

Numbers in parentheses are percentage unless otherwise indicated. SD Standard Deviation, ED Emergency Department, BPPV Benign Paroxysmal Positional Vertigo.
Table 3
Primary and secondary outcome measures
Characteristic
Vertigoa , mm
Baseline
2 hr
Differenceb
Nauseaa , mm
Baseline
2 hr
Differenceb
Readministration, %

Promethazine N = 92

Lorazepam N = 92

73.0 16.5
26.2 15.2
46.5 18.2

69.3 15.5
42.8 20.7
25.7 15.3

0.114
< 0.001
< 0.001

46.4 15.2
17.3 10.9
28.7 13.8
9 (9.7)

49.4 13.6
29.5 14.9
22.8 12.1
27 (29.3)

0.158
< 0.001
0.002
0.001

p value

Plus-minus values are mean SD (Standard Deviation). a Measured by visual analog scale. b The 2-hour minus pretreatment change.

in the ED. The findings of their study demonstrated

that 86% of the dimenhydrinate-treated patients were
ready to go home 2 hours after intervention, compared with 69% in the lorazepam group. Moreover, patients in the lorazepam group experienced a 1.8-unit
greater increase in drowsiness, which obviously has
impact on the prolonged discharge of patients.
Patients presenting with acute nausea and vomiting
generally require IV infusions during the ED stay [26].
Two different categories of medications are commonly
used in ED: vestibular suppressants and antiemetics
when pharmacological therapy is necessary to decrease
symptoms in the acute setting. Most of the vestibular suppressants have anticholinergic or antihistamine
properties, giving them antiemetic qualities in addition
to the effects on vertigo [27]. Antihistamines appeared
to have a suppressive effect on the central emetic center to relieve the nausea and vomiting correlated with
vertigo [28]. Dopamine, histamine, acetylcholine, and
serotonin are transmitters acting on these sites to pro-

duce vomiting [29]. When nausea and vomiting are

prominent, the use of a vestibular suppressant possessing antiemetic effect (such as promethazine and lorazepam) appeared useful to control symptoms. These
medications typically have central dopamine antagonist effects and are supposed to prevent emesis by inhibition at the chemoreceptor trigger zone. A major adverse effect of both categories is drowsiness, although
this effect possibly contributes to the therapeutic effect
as well [27]. The function of promethazine in the management of vertigo and nausea in ED was inadequately
studied in trials. Promethazine, a phenothiazine derivative, exerts its effect by blocking dopamine (D2) receptors in the brain and acetylcholine receptors in the
vestibular apparatus [16]. According to the 2005 National Hospital Ambulatory Survey, promethazine is
among the top generic medications prescribed in the
ED [30]. This antiemetic agent has the advantages
of low cost, slow intramuscular absorption, and long
elimination half-life [31].

A. Amini et al. / Intravenous promethazine versus lorazepam for the treatment of peripheral vertigo

Prior studies reported effective use of promethazine

in the treatment of nausea and vomiting for patients
having ear surgery. In this regard, Khalil et al. [32]
demonstrated that promethazine 25 mg administered
intravenously was more effective than placebo for the
treatment of postoperative nausea and vomiting after
middle ear surgery. During the 24-hour period, the incidence of postoperative nausea and vomiting was reduced from 74% (placebo) to 39% (promethazine; p =
0.03).
In 2006, Habib et al. [33] compared the efficacy
of ondansetron with promethazine for treatment of
postoperative nausea and vomiting in patients failing
ondansetron prophylaxis. The complete response (no
nausea and vomiting) was 68% after administration
of promethazine and 50% after ondansetron administration (p < 0.0001). Moreover, in 2008, Bruade et
al. [34] compared IV ondansetron (4 mg) and promethazine (25 mg) among ED patients with undifferentiated nausea. They reported that promethazine and
ondansetron have similar efficacy in reducing nausea.
However, promethazine was associated with significantly more sedation than ondansetron. In the present
study, we used the VAS score to measure the intensity of nausea pre- and post-intervention. The scale for
nausea has been studied in previous trials [3537].
Our findings revealed the superiority of promethazine 25 mg/mL over lorazepam 2 mg/dL, however it
was relatively offset by an increased risk of some AEs.
In this study, the main side effect inthe promethazine
treatment group was drowsiness. Although promethazine has a greater effect on H1 receptors, it has
been associated with more sedation than some of the
other common antiemetic agents used in the ED [26,
34,38]. Further possible adverse effects include dry
mouth, urinary retention, nervousness, respiratory depression, phlebitis as well as other injection site reactions, extrapyramidal symptoms, change in blood pressure, and bradycardia [39]. However, many of these effects rarely occur in the general population. Furthermore, occurrence of EPS was reported in two patients
treated with promethazinein this trial. A 1984 case report of incident of EPS secondary to promethazine administration described a patient experienced reaction
after repeated doses [40]. Our incidence of EPS with
promethazine appeared much lower than the 1644%
noted in ED patients receiving prochlorperazine as another member of phenothiazine group [41,42]. Both
medications in this trial were generally considered safe
at the doses given, and we found little evidence to
refute this. Patients in the lorazepam group experienced increased lethargic condition, however lethargy
returned to baseline during ED evaluation.

45

5. Limitations
There are several limitations to our trial. Data reporting my have been confounded by patients subjective
sensation of symptoms. Patients symptoms may have
been reported differently depending on the individuals perception of discomfort. Another limitation of the
study was the evaluation of vertigo initially and after
only a period of 2 hours. Several outcome measures
during different time intervals could make our findings more comprehensive. Moreover, this study lacked
a placebo control group. A separate placebo control
group would have been principally useful in documenting efficacy and comparing vertigo score and change in
nausea intensity. We tried to select the most common
doses used in clinical practice however various dosages
may have different effects. We did not compare the efficacy and safety of several effective dosages of study
medications. Thus, future study to examine the effectiveness of alternative treatment options with different
dosing is warranted.

6. Conclusions
Our study demonstrated that a single IV dose of
promethazine has superior efficacy at vertigo reduction
compared with lorazepam. Moreover, we found statistical difference between the study medications in terms
of efficacy at nausea reduction. Our analysis suggested
that promethazine plays an important role in the treatment of peripheral vertigo. These findings should be
generalizable to other patients presenting with vertigo
likely to be of peripheral origin. Future trials may also
consider the therapeutic efficacy of promethazine versus dimenhydrinate in patients presenting to the ED
with acute peripheral vertigo.

Acknowledgments
Financial support: The study was financially supported by Shahid Beheshti University of Medical Sciences (SBMU). Supplies of promethazine, lorazepam
were provided by Sina Daru Pharamaceutical Company (Iran). The SBMU and pharmaceutical company
had any role in the study design, data collection, analysis or interpretation, or in the writing of the paper.

Conflicts of interest
None.

46

A. Amini et al. / Intravenous promethazine versus lorazepam for the treatment of peripheral vertigo

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