The Journal of Emergency Medicine, Vol. 35, No. 3, pp.

247–253, 2008
Published by Elsevier Inc.
Printed in the USA
0736-4679/08 $–see front matter

doi:10.1016/j.jemermed.2007.09.047

Original
Contributions

PROCHLORPERAZINE VS. PROMETHAZINE FOR HEADACHE TREATMENT IN

THE EMERGENCY DEPARTMENT: A RANDOMIZED CONTROLLED TRIAL
James E. Callan, MD, LCDR, MC, USN,* Mark A. Kostic, MD, CDR, MC, USN,† Ethan A. Bachrach, MD,†
and Thomas S. Rieg, PhD‡

*Department of Emergency Medicine, Naval Hospital, Okinawa, Japan, †Department of Emergency Medicine, Naval Medical Center
Portsmouth, Portsmouth, Virginia, and ‡Naval Medical Center Portsmouth, Portsmouth, Virginia
Reprint Address: James E. Callan, MD, LCDR, MC, USN, Department of Emergency Medicine, Naval Hospital, Okinawa, Japan, PSC 482,
Box 2544 FPO AP 96362; E-mail: Jcallan1@aol.com

e Abstract—Headache is a very common medical com-
plaint. Four to six percent of the population will have a
debilitating headache in their lifetime; and 1–2% of all
Emergency Department (ED) visits involve patients with
This abstract was presented at the 2006 Society of Academic
Emergency Medicine, resulting in the abstract being published
in the May issue of the Journal of Emergency Medicine. It was
also presented at the Naval Medical Center Portsmouth re-
search competition in May 2006, and at the Government Ser-
vices chapter meeting of the American College of Emergency
Physicians in March 2006.
The views expressed in this article are those of the author(s)
and do not necessarily reflect the official policy or position of
the Department of the Navy, Department of Defense, or the
United States Government. The Chief, Navy Bureau of Medi-
cine and Surgery, Washington, DC, Clinical Investigation Pro-
gram sponsored this study (CIP #P05-005). The local Institu-
tional Review Board approved this study and written consent
was obtained by all participants before being enrolled. I am a
military service member (or employee of the U.S. Govern-
ment). This work was prepared as part of my official duties.
Title 17 U.S.C. 105 provides that ‘Copyright protection under
this title is not available for any work of the United States
Government.’ Title 17 U.S.C. 101 defines a United States
Government work as a work prepared by a military service
member or employee of the United States Government as part
of that person’s official duties.
headaches. Although promethazine is used frequently, it
has never been studied as a single-agent treatment in un-
differentiated headache. We hypothesized that prometha-
zine would be superior to prochlorperazine in the treatment
of headache. We conducted a prospective, double-blinded,
randomized, controlled trial on patients presenting to our
ED between May and August 2005 with a chief complaint of
headache. Each subject was randomized to receive either
intravenous promethazine 25 mg or prochlorperazine 10
mg, and graded the intensity of their headache on serial
100-mm visual analog scales (VAS). Patients with dystonic
reactions or akathesia were treated with diphenhydramine.
Adequate pain relief was defined as an absolute decrease in
VAS score of 25 mm. After discharge from the ED, patients
were queried regarding the recurrence of headache symp-
toms, the need for additional pain medications, and the
occurrence of any side effects since discharge. Thirty-five
patients were enrolled in each group. Both drugs were
shown to be effective in treatment of headaches. Prochlor-
perazine provided a faster rate of pain resolution and less
drowsiness when compared to promethazine. Both medica-
tions were individually effective as abortive therapy for
headache. Prochlorperazine was superior to promethazine
in the rate of headache reduction and rate of home drows-
iness, with similar rates of akathesia, nausea resolution,
patient satisfaction, and headache recurrence within 5 days
of discharge. Published by Elsevier Inc.
e Keywords—headache; migraine; treatment; prochlor-
perazine; promethazine

RECEIVED: 24 February 2007; FINAL SUBMISSION RECEIVED: 1 September 2007;

ACCEPTED: 13 September 2007
247
248
INTRODUCTION
Background
Headache is a very common medical complaint. Four to
six percent of the population will have a debilitating
headache in their lifetime, and 1–2% of all Emergency
Department (ED) visits involve patients with headaches
(1,2). Potentially devastating medical illness is present in
only a minority of cases. Most headaches are of benign
etiology, such as a migraine, tension, or cluster head-
ache. Strategies to treat headache vary substantially be-
tween regions and even within individual EDs. Treatment
options commonly available to emergency physicians in-
clude ergot derivatives, triptans, anti-psychotics, non-
steroidal anti-inflammatory drugs, steroids, anti-emetics,
and opioids (3–13).
Importance
Multiple studies have addressed various treatment regi-
mens for headache. In EDs, the most effective medica-
tions have been shown to be the ergot derivatives, the
triptans, and the phenothiazines (12–23). Lacking the
vasoconstrictive properties of ergots and triptans, phe-
nothiazines have recently received more attention. Their
mechanism of action includes blockade of the central
dopamine receptors that mediate meningeal artery vaso-
dilatation, specifically D2, and variably D1, D3, D4, and
D5 (24,25). Additionally, phenothiazines have the added
benefit of effectively treating the frequently associated
symptoms of nausea and vomiting. Prochlorperazine
(Compazine®, GlaxoSmithKline, Middlesex, UK) is the
most commonly utilized and best-studied phenothiazine
in headache abortive therapy. Promethazine (Phenergan®,
Baxter, Deerfield, IL) gained popularity for headache
treatment due to both a manufacturing shortage of pro-
chlorperazine and the black box warning applied to
droperidol. Because it is from the same class as prochlor-
perazine, it seemed logical that promethazine would be
an effective therapy. Anecdotally this seemed to be true,
yet no clinical trial has been performed to assess its
efficacy as single-agent therapy.
Goals of this Investigation
In our experience, promethazine seemed to be superior to
prochlorperazine in the treatment of headache and its
associated symptoms. Therefore, we hypothesized that
promethazine would be superior to prochlorperazine in
both side-effect profile and efficacy in patients present-
ing to the ED with a primary benign headache.
J. E. Callan et al.
MATERIALS AND METHODS
Study Design
We conducted a prospective, double-blinded, random-
ized, controlled trial on consecutive patients presenting
to our ED with the chief complaint of headache between
May and August 2005. This study was in accord with the
Standards of the Committee of Human Experimentation
and was approved by the local Institutional Review
Board.
Selection of Participants
In our young population, many patients claim they have
“migraine” headaches without any formal diagnoses or
without meeting the strict International Headache Soci-
ety guidelines that require five prior episodes. In our
experience, many of these patients had resolution of their
headaches with phenothiazines. Therefore, we decided
this study would include all patients between the ages of
18 and 65 years who did not meet the exclusion criteria
and who presented with a benign headache. All enrolling
providers were told that a benign headache consisted of
either a headache that was similar to prior headaches, a
headache with gradual increase in intensity of pain, a
headache without neurologic deficits, a headache not
described as the “worst headache of their lives,” or a
headache without thunderclap onset. Thus, the study
would potentially include those patients with undiag-
nosed migraine, tension, or cluster headaches. Patients
were excluded if they had prior involvement in this
study, were pregnant, had a temperature ⬎ 38.5°C
(100.5°F), had a diastolic blood pressure ⬎ 104 mm Hg,
had a history of non-skin cancer, described their current
headache as atypical in character or location from their
usual headaches, had altered mental status, had the
“worst headache of their life,” had neurological symp-
toms, had a history of trauma, had thunderclap onset, had
meningeal signs, or had a headache post lumbar punc-
ture. Additionally, patients were excluded if they had a
known allergy to the study drugs, or reported use of ergot
amines, anti-emetics, anti-psychotics, or sedatives in the
previous 24 h.
Interventions
A study investigator obtained informed consent from
each patient. To maintain blinding, a standardized order
sheet was utilized to prevent foreknowledge or the ability
to alter subject assignment. Vital signs were monitored
on a routine basis per standard ED protocols. Each pa-
Prochlorperazine vs. Promethazine for Headache in the ED
tient had an intravenous catheter placed, received the
study medication, and a 500-mL normal saline bolus.
On the basis of a computer-generated random num-
bers table, each subject was randomized to receive a
2-mL solution containing either promethazine (25 mg) or
prochlorperazine (10 mg) intravenously, over a 2-min
period, followed by a 10-mL flush of normal saline. Drug
preparation and subject randomization were performed
by a research pharmacist before patient enrollment. The
study medication doses were chosen to reflect the most
common doses used in emergency medicine practice.
Study results reflect only these dosages.
Methods of Measurement
Patients graded the intensity of their headache on sepa-
rate 100-mm non-hatched visual analog scales at 0, 15,
30, 45, and 60 min. Time zero began immediately after
administration of the study drug (26,27). At these same
intervals, patients also completed a questionnaire regard-
ing symptoms of nausea, anxiety, or jitteriness. If the
provider felt the patient was having akathesia or a dys-
tonic reaction, diphenhydramine 25 mg was given intra-
venously (28). Diphenhydramine administration was
treated as a rescue medication and no further VAS scores
were recorded.
A similar prior study used a 25-mm difference in
mean VAS score reduction between groups to show a
clinical benefit (2). Based on this study, we defined
adequate pain relief as an absolute decrease in the mean
VAS score of 25 mm. If this reduction in pain was not
achieved after 30 min, the treating physician had the
option of providing a rescue medication and terminating
the study. Two separate analyses were performed, one at
30 min and one at 60 min. The primary analysis was at
60 min, and all patient number calculations were based
on that time interval. This analysis included only those
patients who did not receive a rescue medication or
diphenhydramine before 60 min. Because 34% of pa-
tients received either a rescue medication or diphenhy-
dramine at 30 min, a separate analysis was performed at
30 min that included all patients. Only the VAS scores
recorded up to the point of rescue therapy were included.
After discharge from the ED, patients were contacted
and asked a standard set of questions regarding the recur-
rence of headache symptoms, satisfaction with medication,
and the occurrence of drowsiness or agitation.
Outcome Measures
The primary outcome measure was the difference in pain
scores between the prochlorperazine and promethazine
249
groups, measured both as the absolute difference be-
tween the means at 30 and 60 min, as well as the
difference between the rates of decline.
Secondary outcome measures were the rates of
akathesia, the need for rescue medications (other pain
medications or diphenhydramine), nausea resolution in
the department, recurrence of headache within 5 days of
discharge, drowsiness within 1 day of discharge, and
total patient satisfaction with the study drug.
Primary Data Analysis
Thirty-two patients were needed in each group to find a
25-mm difference between the group mean on the VAS
at 60 min, with a power of 0.80 and an alpha of 0.05.
Expecting a 10% dropout rate, 35 subjects were enrolled
in each group. The groups were compared using a t-test on
gender, race, and age; and a chi (with Yates correction)-
squared test on severity of presenting headache, to deter-
mine if they were similar. The individual VAS measure-
ments were compared using a repeated measures analysis
of variance (ANOVA) test.
RESULTS
A total of 887 patients presented during the enrollment
time frame with a chief complaint of headache. All
patients were screened by departmental researchers.
There were 753 patients who met at least one of the
exclusion criteria. The vast majority of excluded patients
described a headache that differed from prior headaches
in either location or character. On chart review, most of
these patients had a discharge diagnosis of benign head-
ache, but at the time of initial evaluation were excluded
from the study. Eighteen patients refused to be in the
study and 32 patients were missed. Another 14 patients
were not enrolled because one of the attending physi-
cians declined to participate in the study. Seventy pa-
tients were enrolled in the study, with 35 receiving
prochlorperazine and 35 receiving promethazine (Figure
1). An intention-to-treat analysis was performed, includ-
ing 3 subjects who dropped out before study completion,
and another subject that was subsequently diagnosed
with aseptic meningitis the following day.
Using t-tests and chi (with Yates correction)-squared
tests, it was established that the groups did not differ
statistically in age, race, sex, or severity of presenting
headache (Table 1). Those patients lost to follow-up
were distributed evenly between both groups and in-
cluded in the Table 1 analysis. For patients lost to
follow-up, the secondary outcomes that could not be
250 J. E. Callan et al.

Patients with Headache

887

# Enrolled # Excluded # Missed/Refused

70 753 64

# Missed # Refused
46 18

Figure 1. Flow chart of patients.

established before discharge were not used in the resolution, and rates of agitation were all similar between
analysis for Table 2. the groups. All patients with akathesia were successfully
At 30 min, 69% (20/29) in the prochlorperazine group treated with diphenhydramine. The rate of drowsiness
and 39% (n ⫽ 33) in the promethazine group had a after discharge from the ED was greater in the prometh-
reduction in VAS ⬎ 25 mm (p ⫽ 0.006), which was azine group (p ⫽ 0.002) (Table 2). Eighty-five percent of
statistically significant (Table 2). For these patients, a patients were successfully contacted for follow-up ques-
repeated measures ANOVA showed that the 13.5-mm tioning post-discharge.
difference between the mean VAS scores for each group
was not significant (p ⫽ 0.581). However, the rates of
decline of the VAS scores were significantly greater in DISCUSSION
the prochlorperazine group (p ⫽ 0.013), signifying that
Both prochlorperazine and promethazine effectively
this group of patients had resolution of their headaches
treated headache in the ED, but the rate by which pro-
faster than the promethazine group (Figure 2).
chlorperazine diminished headache was superior. At 30
At 60 min, 91% (21/23) in the prochlorperazine group
min, significantly more patients in the prochlorperazine
and 47% (16/23) in the promethazine group had a VAS
group had a reduction in their headache ⱖ 25 mm. By 60
reduction of ⬎ 25 mm (p ⫽ 0.133), which failed to reach
min, there was no statistically significant difference. It is
statistical significance (Table 2). The absolute mean
possible that this was due to an inadequate number of
reduction in VAS score was 19 mm greater in the patients reaching 60 min without rescue drugs. Thirty-
prochlorperazine group. Although statistical signifi- four percent of patients in each group required a rescue
cance for this difference was not achieved (p ⫽ 0.439), medication or diphenhydramine by the 60-min mark.
there was a significant difference between the groups in Previous studies following a single drug over time
the rate at which the VAS scores declined over 60 min showed that a change of 13 mm is clinically significant.
(p ⫽ 0.028) (Figure 3). Eighty percent of the prochlorperazine group and 71% of
Headache recurrence, rates of akathesia, need for res- the promethazine group met this mark (26,27,29). Be-
cue medications in the ED, patient satisfaction, nausea cause these studies did not address what would be a
clinically significant change between groups, we used a
similar headache study and set a difference of 25 mm
Table 1. Mean and 95% Confidence Intervals for Subject between the mean VAS scores as our threshold for clin-
Variables for the Two Study Groups
ical significance. The 19.5-mm difference found in our
Prochlorperazine Promethazine study did not reach this previously set threshold (2).
Variable n ⫽ 35 n ⫽ 35 p-Value Prochlorperazine also produced less home drowsi-
Mean age (years) 28.3 29.5 0.550 ness, but was similar in rates of akathesia, nausea reso-
Female % 77 85 0.356 lution, and patient satisfaction.
Caucasian % 54 42 0.537 The akathesia rate reported in this study (27%) was
VAS time 0 75.2 70.7 0.340
much higher than reported in previous studies (10%)
VAS ⫽ visual analog scale. (14). This rate may be elevated due to the study defini-
Prochlorperazine vs. Promethazine for Headache in the ED 251

Table 2. Descriptive and Inferential Statistics Comparing the Two Study Drugs for Each Recorded Measure

Characteristic Prochlorperazine (n ⫽ 35) Promethazine (n ⫽ 35) p-Value

VAS reduction at 30 min (mm) 36.43 23.66 0.581

VAS reduction at 60 min (mm) 64.27 45.22 0.439
30 min VAS reduction ⬎ 25 mm *n ⫽ 29 20 (69%) *n ⫽ 33 13 (39%) 0.006
60 min VAS reduction ⬎ 25 mm *n ⫽ 23 21 (91%) *n ⫽ 23 16 (47.9%) 0.133
Headache within 5 days (%) 15 (45%) 21 (39%) 0.444
Akathesia in ED (%) 10 (28.6%) 9 (25.7%) 0.779
Rescue medication in ED (%) 12 (34%) 12 (34%) 0.423
Patient satisfaction (%) 19 (54.3%) 19 (54.3%) 0.499
Home drowsiness (1 day) (%) 14 (40%) 25 (71.4%) 0.002
Home agitation (%) 13 (37%) 8 (22.9%) 0.284
Nausea resolution in ED (%) †n ⫽ 17 16 (94%) †n ⫽ 20 14 (70.0%) 0.587

* Patients not receiving rescue medication/diphenhydramine before specified time.

† Number of patients presenting with nausea.

tion of akathesia, which included patient-reported jitteri-
ness. Upon reviewing the treating physicians’ notes,
akathesia was reported in 18.5% of patients. Although
the rate remained higher than expected, it was more in
line with the higher estimates (as high as 15%) seen in
other studies (30). It is conceivable that prior studies
underestimated true akathesia rates because a patient
feels the symptoms of akathesia long before the outward
appearance that would normally trigger therapy.
Diphenhydramine was required in 7 patients in the
prochlorperazine group and 6 patients in the prometha-
zine group. It has been well documented that diphenhy-
dramine can cause drowsiness, but because both groups
had similar usage of diphenhydramine, patients that re-
ceived diphenhydramine were not excluded from any of
the secondary outcome analyses, including home drows-
iness. Excluding these patients would likely decrease the
total percentage of drowsiness in each group, but would
not likely change the ratio difference between the groups.
The mechanism of action employed by phenothia-
zines in treating headache, specifically migraine, has not
been fully elucidated, but is thought to be related to
dopamine blockade. It has also been hypothesized that
the propensity of phenothiazines to cause sedation may

100

90

80

70
Mean (95% CI) VAS Score

60

Prochlorperazine
50
Promethazine

40

30

20

10

0
0 15 30
Time (minutes)

Figure 2. The comparison of mean VAS scores over time for all subjects at 30 min (n ⴝ 70).
252
100
90
80
70
Mean (95% CI) VAS Scores
60
50
40
30
20
10
0
0 15
Time (minutes)
Figure 3. The comparison of mean VAS scores over time for those subjects who reached 60 min (n ⴝ 46).
also be a factor. In this study, the drug that was more
sedating was found to be less effective in headache
treatment. Future studies could be designed to collect
data on all patients for at least 60 min and standardize
rescue and discharge medication regimes.
Limitations
Patients with undifferentiated primary headaches were
enrolled, as opposed to only enrolling those that met the
strict definition of migraine. Although this may have
affected the results, we felt that this was more consistent
with the patient population that a typical emergency
physician encounters on a daily basis.
Greater power would have been achieved to detect a
difference in the mean VAS score reductions at 60 min if
all subjects remained in the ED for the collection of all
five data points. We did not wish to inconvenience our
patients in this way. However, it is reasonable to con-
clude that there is a clinical difference between these
medications based upon the significantly greater rate of
VAS reduction in the prochlorperazine group.
We decided to use a patient-based diagnosis of akathe-
sia, rather than a provider-based diagnosis of akathesia. We
feel that this more closely approximated true akathesia
because patients feel jittery before outward clinical signs
that providers would use for diagnosis.
In summary, although both medications were effec-
tive in treating headache in the ED, prochlorperazine was
J. E. Callan et al.
Prochlorperazine
Promethazine
30 45 60
superior to promethazine, with less drowsiness and sim-
ilar rates of akathesia.
Acknowledgments—We would like to thank Mr. Timothy
Gendron and the pharmacy staff for preparing the medications.
We would especially like to thank the nurses, doctors, and staff
for their outstanding support of this project.
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