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PROMETHAZINECOMPAREDWITH
METOCLOPRAMIDEFORHYPEREMESISGRAVIDARUM
A RANDOMIZEDCONTROLLEDTRIAL
Presenter Dr Surya Prasad rimal, Junior resident
Moderator Dr Pritha Basnet, Assistant professor
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OBSTETRICS & GYNECOLOGY
VOL. 115, NO. 5, MAY 2010
Peng Chiong Tan, Pwint Phyu Khine, NarayananVallikkannu, and Siti Zawiah Omar
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Location: Department of Obstetrics and Gynecology,
University of Malaya, Lembah Pantai, Kuala Lumpur,
Malaysia
Duration : From November 25, 2008,
to August 14, 2009
Subjects: A total of 73 and 76 women, randomized tometoclopramide and promethazine, respectively
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OBJECTIVES
To compare the effects of promethazine with
metoclopramide for hyperemesis gravidarum.
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OBJECTIVES
VERSUS
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INTRODUCTION
Hyperemesis gravidarum is practically defined as
pernicious vomiting in pregnancy that requires
hospitalization.
It typically is associated with dehydration, electrolyte
disturbances, and starvationwith consequent weight
loss.
It affects 0.3% to 2.3% of the pregnant population,
whereas nausea and vomiting of pregnancy is far
more common, affecting up to 85% of pregnant women.
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The mainstays of therapy: rehydration,
antiemetics, and enhancement of coping
mechanisms.
ACOG 2004 guidelines
dimenhydrinate,metoclopramide,or
promethazine as first-line antiemetic.
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Hyperemesis Gravidarum
When the joy of creating life turns
into a struggle for survival and hope
I wish that I had never tried to get
pregnant
I wish that in a few months I would
be able to hold my baby
I Wish . . .
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METOCLOPRAMIDE
increases the movements
or contractionsof the muscles
prokinetic
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Side Effects
does not cause as many side effects as many other
medicines used to prevent nausea and vomiting.
May include:
Sleepiness or confusion.
Twitchingor muscle spasms.
Decreased blood pressure(hypotension).
Rapid or uncontrolled movements of lips and tongue.
Contra indications:
narrow-angle glaucoma, prostatedisease, severe low
blood pressure, or rapid, irregular heartbeats.
http://www.webmd.com/brain/tic-disorders-and_twitcheshttp://www.webmd.com/pain-management/muscle-spasms-cramps-charley-horsehttp://www.webmd.com/hypertension-high-blood-pressure/guide/diastolic-and-systolic-blood-pressure-know-your-numbershttp://www.webmd.com/heart/understanding-low-blood-pressure-basicshttp://www.webmd.com/oral-health/picture-of-the-tonguehttp://www.webmd.com/eye-health/glaucoma-eyeshttp://www.webmd.com/urinary-incontinence-oab/picture-of-the-prostatehttp://www.webmd.com/heart/understanding-low-blood-pressure-basicshttp://www.webmd.com/heart/understanding-low-blood-pressure-basicshttp://www.webmd.com/heart/understanding-low-blood-pressure-basicshttp://www.webmd.com/heart/understanding-low-blood-pressure-basicshttp://www.webmd.com/urinary-incontinence-oab/picture-of-the-prostatehttp://www.webmd.com/eye-health/glaucoma-eyeshttp://www.webmd.com/oral-health/picture-of-the-tonguehttp://www.webmd.com/heart/understanding-low-blood-pressure-basicshttp://www.webmd.com/hypertension-high-blood-pressure/guide/diastolic-and-systolic-blood-pressure-know-your-numbershttp://www.webmd.com/pain-management/muscle-spasms-cramps-charley-horsehttp://www.webmd.com/brain/tic-disorders-and_twitches8/10/2019 Promethazine Compared With
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PROMETHAZINE
Promethazine, a phenothiazine derivative,
Acts primarily as a strong antagonistof
the H1receptor(antihistamine) and a
moderate mACh receptorantagonist(anticholinergicand also has weak to
moderate affinityfor the 5-HT2A,[11]5-
HT2C,[11]D2,
[12][13]and 1-adrenergic
receptors,[14]where it acts as an antagonistat all sites, as well.
http://en.wikipedia.org/wiki/Receptor_antagonisthttp://en.wikipedia.org/wiki/H1_receptorhttp://en.wikipedia.org/wiki/H1_receptorhttp://en.wikipedia.org/wiki/H1_receptorhttp://en.wikipedia.org/wiki/Antihistaminehttp://en.wikipedia.org/wiki/Muscarinic_acetylcholinehttp://en.wikipedia.org/wiki/Anticholinergichttp://en.wikipedia.org/wiki/Affinity_(pharmacology)http://en.wikipedia.org/wiki/5-HT2A_receptorhttp://en.wikipedia.org/wiki/5-HT2A_receptorhttp://en.wikipedia.org/wiki/Promethazinehttp://en.wikipedia.org/wiki/5-HT2C_receptorhttp://en.wikipedia.org/wiki/5-HT2C_receptorhttp://en.wikipedia.org/wiki/5-HT2C_receptorhttp://en.wikipedia.org/wiki/Promethazinehttp://en.wikipedia.org/wiki/D2_receptorhttp://en.wikipedia.org/wiki/D2_receptorhttp://en.wikipedia.org/wiki/Promethazinehttp://en.wikipedia.org/wiki/Alpha-1_adrenergic_receptorhttp://en.wikipedia.org/wiki/Alpha-1_adrenergic_receptorhttp://en.wikipedia.org/wiki/Alpha-1_adrenergic_receptorhttp://en.wikipedia.org/wiki/Alpha-1_adrenergic_receptorhttp://en.wikipedia.org/wiki/Promethazinehttp://en.wikipedia.org/wiki/Promethazinehttp://en.wikipedia.org/wiki/Alpha-1_adrenergic_receptorhttp://en.wikipedia.org/wiki/Alpha-1_adrenergic_receptorhttp://en.wikipedia.org/wiki/Alpha-1_adrenergic_receptorhttp://en.wikipedia.org/wiki/Alpha-1_adrenergic_receptorhttp://en.wikipedia.org/wiki/Alpha-1_adrenergic_receptorhttp://en.wikipedia.org/wiki/Promethazinehttp://en.wikipedia.org/wiki/D2_receptorhttp://en.wikipedia.org/wiki/D2_receptorhttp://en.wikipedia.org/wiki/Promethazinehttp://en.wikipedia.org/wiki/5-HT2C_receptorhttp://en.wikipedia.org/wiki/5-HT2C_receptorhttp://en.wikipedia.org/wiki/5-HT2C_receptorhttp://en.wikipedia.org/wiki/5-HT2C_receptorhttp://en.wikipedia.org/wiki/Promethazinehttp://en.wikipedia.org/wiki/5-HT2A_receptorhttp://en.wikipedia.org/wiki/5-HT2A_receptorhttp://en.wikipedia.org/wiki/5-HT2A_receptorhttp://en.wikipedia.org/wiki/5-HT2A_receptorhttp://en.wikipedia.org/wiki/Affinity_(pharmacology)http://en.wikipedia.org/wiki/Anticholinergichttp://en.wikipedia.org/wiki/Muscarinic_acetylcholinehttp://en.wikipedia.org/wiki/Muscarinic_acetylcholinehttp://en.wikipedia.org/wiki/Muscarinic_acetylcholinehttp://en.wikipedia.org/wiki/Antihistaminehttp://en.wikipedia.org/wiki/H1_receptorhttp://en.wikipedia.org/wiki/H1_receptorhttp://en.wikipedia.org/wiki/H1_receptorhttp://en.wikipedia.org/wiki/H1_receptorhttp://en.wikipedia.org/wiki/Receptor_antagonist8/10/2019 Promethazine Compared With
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SIDEEFFECTS
Tardive dyskinesia
Confusion in the elderly
Drowsiness, dizziness, fatigue, more
rarely vertigoDry mouth
Constipation
Chest discomfort/pressure (typically in
cases when patient is already takingmedication for high blood pressure)
http://en.wikipedia.org/wiki/Tardive_dyskinesiahttp://en.wikipedia.org/wiki/Vertigo_(medical)http://en.wikipedia.org/wiki/Vertigo_(medical)http://en.wikipedia.org/wiki/Tardive_dyskinesiahttp://en.wikipedia.org/wiki/Tardive_dyskinesiahttp://en.wikipedia.org/wiki/Tardive_dyskinesia8/10/2019 Promethazine Compared With
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METHODOLOGY
Women hospitalized for the first time in their
current pregnancies with presumed hyperemesis
gravidarum were approached
Informed written consent.Ethical approval
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INCLUSIONCRITERIA
Clinical hyperemesis gravidarum with dehydration
and detectable ketonuria by urine dipstick at a
gestation of 16 weeks or less.
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EXCLUSIONCRITERIA
multiple gestation,
Established nonviable pregnancy,
preexisting medical condition that can cause
nausea and vomiting (eg, culture provensymptomatic urinary tract infection or dengue fever),
gastrointestinal causes of vomiting (eg,
gastroenteritis),medical causes of vomiting (eg, diabetic
ketoacidosis),
known allergy to metoclopramide /promethazine
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PRIMARYOUTCOME
well-beingvisual numerical rating scale score and
frequency of vomiting in the first 24 hours
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SECONDARYOUTCOMES
visual numerical rating scale scores for nausea at
enrolment and at 8, 16, and 24 hours;
adverse symptoms profile;
ketonuria status at the end of the 24-hour main studyperiod;
treatment curtailment during the main study period;
total doses of intravenous antiemetic needed during
hospitalization; admission- to-discharge interval; and
time needed for intravenous rehydration
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ASSIGNMENTTOTREATMENTGROUP
Participants were recruited by providers as they
were admitted to the gynecology ward.
After obtaining consent, participants were
assigned randomly by the sequentialopening ofnumbered, sealed, opaque envelopes stating
Drug A or Drug B.
These numbered envelopes were prepared by
an author (P.P.K.) in random blocks of four or
eight using a computer-generated randomization
sequence
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Study drugs were placed in identical vials.
Each vial contained a colorless 5-mL solution,
and the vial was labeled as A or B to effect
double blinding of drug allocation.
The solutions contained either 10 mg of
metoclopramide or 25 mg of promethazine.
The contents of vials A and B was swappedbetween metoclopramide and promethazine
periodically to strengthen blinding; that is, the
study drugs were in vials labeled differently at
different stages of the study.This was not revealed to providers.
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Antiemetic therapy as randomly allocated was
administered by slow injection into an indwelling
intravenous catheter over 1 to 2 minutes by
providersjust after randomization and 8, 16,and 24 hours later for a full course of four doses
as per trial protocol.
Participants were instructed to chart vomitingepisodes as they occurred during the 24-hour
study period and to mark the nausea visual
numerical rating scale (10 points, high score
denoting more severe nausea) before initialadministration of the study drug and 8, 16, and
24 hours after administration of the study drug.
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Also at 24 hours, participants were
asked to mark their perceived well-
being over the study period with a 10-point visual numerical rating scale
(higher score greater well-being) and
to answer a preset questionnaire(yes or no answers) on symptoms
experienced during the study
period.
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At the conclusion of the 24-hour main
study period, the allocated
intravenous study antiemetic could bestopped or continued as allocated or
open-label treatment (either
intravenous or oral) instituted at theproviders discretion.
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SAMPLESIZEESTIMATION
Based on the hypothesis that
metoclopramide will produce an overall
well-being visual numerical rating scale
score at 24 hours that is 1 unit better than
that produced by promethazine (using a10-point visual numerical rating scale),
assuming a visual numerical rating scale
standard deviation of 2, 0.05, and 80%power.
Sixty-four women were required in each
arm.
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Visual numerical rating scale score might not
be normal and that the Mann-Whitney U test
might have to be applied instead of theStudents t test, so, 10% increase to the
enrollment.
For 10% drop-out rate, it was planned toenroll a total of 158 women to perform a
suitably powered study.
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STATISTICALANALYSIS
SPSS 16
Students t test.
Two-by-two categorical data sets were analyzed
with the Fisher exact test and larger categorical
data sets with the 2 test; ordinal data and non
normally distributed continuous data were
analyzed with the Mann-Whitney U test
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Numbers needed to treat were generated using
GraphPad QuickCalc (GraphPad Software Inc., La
Jolla, CA).
P.05 was considered significant
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RESULTS
Primary outcome not significantly different.
Median vomitingfrequency one(range 026) compared
with two(range 026) (P.81) and
Well-beingvisual numerical rating scale score 8(range
110) compared with 7(range 210) (P.24) for themetoclopramide and promethazine arms, respectively
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SECONDARYOUTCOME
nausea visual numerical rating scale
very similar at each time point when
assessed individually.
Length of hospital stay, persistence of ketonuria at 24
hours, overall treatment curtailment, duration of
intravenous rehydration, and total doses of intravenous
antiemetic given during hospitalization were not
different between the trial arms.
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SECONDARYOUTCOME. Questionnaire on symptoms at the end of the 24-hour
main study period, the 3 Ds
drowsiness (58.6% compared with 83.6%,
P.001, number needed to treat to benefit[NNTb] 5),
dizziness (34.3% compared with 71.2%, P.001,
NNTb 3), and
dystonia (5.7% compared with 19.2%, P.02,
NNTb 8) were reported less frequently for
metoclopramide than for promethazine
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CONT.
Difficulty in sleeping, dry mouth, diarrhea,
headache, palpitations, and skin rash were reported
in similar proportions across the trial arms.
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DISCUSSION
A trial directly comparing promethazine with
metoclopramide for hyperemesis gravidarum has
not been done.
However, a three-armed trial of placebo compared
with metoclopramide compared with promethazine(with the first dose of pethidine) for labor analgesia
has shown that metoclopramide and promethazine
are equally effective in reducing the incidence of
nausea and vomiting but that the sedative effectwas more persistent in the promethazine group.
These findings are similar the data of this study .
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Metoclopramide has a desirable effect of
prokineticaction but this study indicate
that esophageal reflux is probably not animportant contributor to symptoms in
hyperemesis gravidarum
September 16, 2009, the U.S. FDAwarned of potential local tissue
damage, including gangrene, from
promethazine injection and mandated ablack box warning on the drug insert.
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LIMITATIONSOFTHESTUDY
The primary outcomes were over a 24-hour time scale
only
recruited on the basis of presumed hyperemesis
gravidarum before investigation results were available.
Later discovery of trial criteria infringements resulted in
postrandomization exclusion of 10 out of 159 (6.3%)
women
small number of participants whose data were
incomplete
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CONCLUSION
Intravenous metoclopramide or promethazine for
hospitalized hyperemesis gravidarum patients
produced similar therapeutic effects.
Metoclopramide resulted in fewer reported sideeffects and treatment curtailment owing to
adverse events.
Intravenous metoclopramide is preferred over
intravenous promethazine for the treatment ofhyperemesis gravidarum.
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Patient had metabolic and
biochemical characteristics
comparable with other women inreported studies of hyperemesis
gravidarum. Hence, findings can
be generalized.
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REFERENCES
1. Verberg MF, Gillott DJ, Al-Fardan N, Grudzinskas JG. Hyperemesisgravidarum, a literature review. Hum Reprod Update 2005;11:52739.
2. Tan PC, Jacob R, Quek KF, Omar SZ. The fetal sex ratio andmetabolic, biochemical, haematological and clinical indicators ofseverity of hyperemesis gravidarum. BJOG 2006;113:7337.
3. Nausea and vomiting of pregnancy. Practice Bulletin No. 52.American College of Obstetricians and Gynecologists. ObstetGynecol 2004;103:80314.
4. Sullivan CA, Johnson CA, Roach H, Martin RW, Stewart DK,Morrison JC. A pilot study of intravenous ondansetron forhyperemesis gravidarum. Am J Obstet Gynecol 1996;174: 15658.
5. Safari HR, Fassett MJ, Souter IC, Alsulyman OM, Goodwin TM.The efficacy of methylprednisolone in the treatment ofhyperemesis gravidarum: a randomized, double-blinblind,controlled study. Am J Obstet Gynecol 1998;179:9214.
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CONT.
6. Ziaei S, Hosseiney FS, Faghihzadeh S. Theefficacy low dose of prednisolone in the treatmentof hyperemesis gravidarum. Acta Obstet GynecolScand 2004;83:2725
7. Lacasse A, Lagoutte A, Ferreira E, Berard A.Metoclopramide and diphenhydramine in thetreatment of hyperemesis gravidarum: effectivenessand predictors of rehospitalisation. Eur J ObstetGynecol Reprod Biol 2009;143:439.
8. Yost NP, McIntire DD, Wians FH Jr, Ramin SM,Balko JA, Leveno KJ. A randomized, placebo-controlled trial of corticosteroids for hyperemesisdue to pregnancy. Obstet Gynecol 2003;102:12504.
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CONT..
9. Buttino L Jr, Coleman SK, Bergauer NK, Gambon C, StanzianoGJ. Home subcutaneous metoclopramide therapy forhyperemesis gravidarum. J Perinatol 2000;20:35962.
10. Bondok RS, El Sharnouby NM, Eid HE, Abd Elmaksoud AM.Pulsed steroid therapy is an effective treatment for intractablehyperemesis gravidarum. Crit Care Med 2006;34:27813.
11. Neri I, Allais G, Schiapparelli P, Blasi I, Benedetto C, FacchinettiF. Acupuncture versus pharmacological approach to reduceHyperemesis gravidarum discomfort. Minerva Ginecol2005;57:4715.
12. Jewell D, Young G. Interventions for nausea and vomiting inearly pregnancy. The Cochrane Database of Systematic Reviews2003, Issue 4. Art. No.: CD000145. DOI: 10.1002/14651858.CD000145.
13. Bsat FA, Hoffman DE, Seubert DE. Comparison of threeoutpatient regimens in the management of nausea and vomitingin pregnancy. J Perinatol 2003;23:5315.
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CONT..
14. Tan PC, Yow CM, Omar SZ. A placebo-controlled trial of oralpyridoxine in hyperemesis gravidarum. Gynecol Obstet Invest2009;67:1517.
15. Tan PC, Jacob R, Quek KF, Omar SZ. Indicators ofprolonged hospital stay in hyperemesis gravidarum. Int JGynaecol Obstet 2006;93:2467.
16. Tan PC, Tan NC, Omar SZ. Effect of high levels of humanchorionic gonadotropin and estradiol (E2) on the severity ofhyperemesis gravidarum. Clin Chem Lab Med 2009;47: 16571.
17. Vella L, Francis D, Houlton P, Reynolds F. Comparison of theantiemetics metoclopramide and promethazine in labour. Br
Med J (Clin Res Ed) 1985;290:11735.18. Brock-Utne JG, Rubin J, Welman S, Dimopoulos GE, Moshal
MG, Downing JW. The action of commonly used antiemeticson the lower oesophageal sphincter. Br J Anaesth 1978;50:2958.
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CONT..
19. Sandhya, Yaddanapudi LN. Evaluation of two antiemetic agents duringoutpatient gynaecological surgery. Singapore Med J 1994;35:2713.
20. U.S. Food and Drug Administration. Information for healthcareprofessionals-intravenous promethazine and severe tissue injury,including gangrene. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcare
Professionals/ucm182169.htm. Retrieved October 3 2009.21. Tan PC, Jacob R, Quek KF, Omar SZ. Readmission risk and metabolic,
biochemical, haematological and clinical indicators of severity inhyperemesis gravidarum. Aust N Z J Obstet Gynaecol 2006;46:44650.
22. Goodwin TM, Montoro M, Mestman JH. Transient hyperthyroidism andhyperemesis gravidarum: clinical aspects. Am J Obstet Gynecol1992;167:64852.
23. Bashiri A, Neumann L, Maymon E, Katz M. Hyperemesis gravidarum:epidemiologic features, complications and outcome. Eur J ObstetGynecol Reprod Biol 1995;63:1358.
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Metoclopramide Promethazine P
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(n73) (n76)
Weight (kg) 54.3 9.1 54.210.5 .95
Body mass index
(kg/m2)
23.0 3.5 22.5 4.2 .45
Coexisting medical
condition
4 (5.5) 6 (7.9) .75
At recruitmentKetonuria(dipstick)
1+ 16 (21.9) 16 (21.1)
2+ 15 (20.5) 12 (15.8)
3+ 32 (43.8) 43 (56.6)
4+ 10 (13.7) 5 (6.6)
Metoclopramide Promethazine P
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Metoclopramide
(n73)
Promethazine
(n76)
P
Nausea score* 5 (2.757) 5 (1.57) .85 .85
Serum sodium
(mmol/L)
134 4 134 2 .78
Serum potassium
(mmol/L)
3.9 0.5 3.9 0.5 .86
Hematocrit 0.39 0.04 0.39 0.03 .57
Pulse 84 13 82 12 .37
Systolic blood
pressure
(mmHg)
114 11 117 12 .15
Diastolic blood
pressuremmH
69 10 71 11 .24
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Primary outcomes
Metoclopramide
(n73)
Promethazine
(n76)
P Relative
Risk
(95% CI)
NNTb*
(95% CI)
Primary
outcomes
Vomiting
episodes
(n144)
1 (05) 2 (03) .81
Well-beingVNRS
(n142)
8 (610) 7 (5.259) .24
7.62.2 7.12.3 .24
Metoclopramide Promethazine P
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Metoclopramide
(n73)
Promethazine
(n76)
P
Secondary outcomes
Nausea score
At recruitment (n143) 5 (2.757 5 (1.57) .85
8 h (n143) 4 (1.55 4 (1.756) .54
16 h (n137) 3 (15) 3 (15) .80
24 h (n126) 2 (15) 2 (14) .99
Metoclopramid Promethazine
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Metoclopramid
e
(n73)
Promethazine
(n76)
Hospital stay (d) (n149) 1.8 (1.52.5) 1.7 (1.52.4)
Ketonuria (dipstick) at the end of
the
study period (n148)
Nil 54 (75.0)) 61 (80.3)
1+ 6 (8.3) 7 (9.2)
2+ 9 (12.5) 5 (6.6)
3+ 3 (4.2) 3 (3.9)
Metoclopramide Promethazine P
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etoc op a de
(n73)
o et a e
(n76)
Intravenous
rehydration (h)
(n147)
42 (3359) 39 (3348.75) .23
Full study drug course
not completed
4/73 (5.5) 9/76 (11.8) .25
Full study drug course
not completed
owing to adverse
events
0/73 (0) 7/76 (9.2) .014
Intravenous antiemetic
doses
4 (44) 4 (44.75) .98
Metoclopramide Promethazine P Relative Risk NNTb*
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Metoclopramide
(n73)
Promethazine
(n76)
P Relative Risk
(95% CI)
NNTb
(95% CI)
Symptoms profile
by questionnaire
(n143)
Felt drowsy 41/70 (58.6) 61/73 (83.6) .001 0.7 (95% CI 0.60.9) 5 (39)
Unable to sleep 12/70 (17.1) 16/73 (21.9) .53 0.8 (0.41.5)
Had dry mouth 28/70 (40.0) 32/73 (43.8) .74 0.9 (0.61.3)
Felt dizzy 24/70 (34.3) 52/73 (71.2)
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