Evidence Table 11

Prevention of postoperative nausea and vomiting: Active-control and placebo-controlled trials

Author
Year
Setting
DesignSurgery typeInclusion criteriaInterventionAllow other medicationRun-in/Wash outAge/Gender/EthnicityOther population characteristicsScreened/Eligible/EnrolledLost Withdrawn/to fu/AnalyzedResults - SatisfactionResults - Resource utilization
Adults: Active- controlled trials
Dolasetron
Burmeister
2003
Single Center
Germany
RCT,
ACT,
DB
Elective extracorporeal shock wave lithotripsy (ESWL)

Mean duration of ESWL: 27.5 min
ASA I or II pts without obstructive pulmonary diseaseA:Dol 12.5 mg iv
B: placebo

Given 10 min before start of procedure
NRNR/NRMean age: 48y
Range: 20–77y

57.7% female

Ethnicity: NR
History of PONV: 35%

History of motion sickness: 27.5%

Smoker: 65%

Female pts ≤ 50 y: 22.5%
NR/NR/40NR/0/40Pt rating for anagesic properties, A vs B, p=0.99:
Excellent: 85% vs 80%
Good: 15% vs 20%
Fair and Poor : both 0% vs 0%

Pt rating for overall quality of anesthesia, A vs B, p=0.32
Excellent: 70% vs 55%
Good: 20% vs 20%
Fair: 5% vs 15%
Poor: 5% vs 10%
Time to discharge, A vs B:
22 min vs 28 min, p<0.05
Granisetron
Ondansetron
Doe
1998
Single center
US
RCT, ACT
DB
Various strabismus surgeriesASA I-III non-obese pts without premedication with antiemeticsA: Ond 4 mg iv
B: Droperidol (Drop) 1.25 mg iv
Premedication of all pts with midazolam 1–2 mg ivNR/No drugs with antiemetic properties nor any opioids allowed prior to surgeryMean age: 30 y
Range: 15–65 y

42% female

Ethnicity: NR
NRNR/NR/45NR/NR/45NRStay in PACU (min): 53.5 vs 50.2, NS
Time from end of surgery to discharge (min): 249.5 vs 266.3, NS
Fortney
1998
Multicenter
North America
(pooled results from 2 studies)
RCT, ACT
DB
Outpatient procedures <2 h
Gyn procedures: 61.0%
musculoskeletal: 17.7%

Anesth. duration: 56.3 min
ASA I or II status non-pregnant pts with a history of motion sickness and PONV undergoing procedures with highly emetogenic potential; pts also had to be addiction freeA:Ond 4 mg iv
B: Droperidol (Dro) 0.625 mg iv
C: Dro 1.25 mg iv
D: placebo
During anesthesia after study drug administration, pts allowed to receive fentanyl, alentanil, or midazolam ≤ 2 mgNR/no drugs with antiemetic properties allowed 24h before surgeryMean Age: 35 y
Range: 18–65y

88.2% female

Ethnicity: NR
History of PONV: 86.0%

History of motion sickness: 61.8%
NR/NR/2061NR/NR/2061Overall pt satisfaction with PONV control
A, B, C, D, results
Very satisfied: 68%, 64%, 70%, 60%
Somewhat satisfied: 16%, 17%, 15%, 20%
Neither satisfied nor dissatisfied: 4%, 5%, 2%, 6%
Somewhat dissatisfied: 6%, 7%, 6%, 7%
Very dissatisfied: 5%, 5%, 4%, 4%
Questionnaire not returned: <1%, 2%, 3%, 3%
Time to home readiness (min): 186 vs 188 vs 207 vs 210, NS
Gan
2004
Single Center
US
ACT
DB
Major breast surgery (100%)

Duration of surgery: 210.9 min
Consecutive non-pregnant pts of ASA I, II, or II status without pacemakers and who were acupuncture-naïveA: Ond 4 mg iv + sham electro-acupoint stimulation
B: active electro-acupoint stimulation
C: placebo + sham electro- acupoint stimulation
All pts received fentanyl 100 micrograms iv and midazolam 2 mg iv per-operationNR/no drugs with antiemetic properties allowed 24h before surgeryMean Age: 45.6 y
Range: NR

100% female

Caucasian: 80%
African American: 20%
History of PONV or motion sickness: 38.7%NR/NR/772/0/75Mean score for Patient Satisfaction (on scale of 0–10, with 10 being most satisfied)
A: 10 (range: 8–10)
B: 8.5 (6.2–10)
C: 5.5 (3–10)
p=0.007 for A & B vs. C
NR
Jokela
2002
Multicenter
Finland
RCT, ACT
DB
Thyroid or parathyroid surgery

mean surgery duration: 114 min
Female adult ASA 1–3 patientsA: Ond 16 mg po
B: Meto 10 mg po
C: Trop 5 mg po

All given with midazolam 7.5 mg
Study medication given with midazolam 7.5 mgNR/NRMean Age: 49.0 y
Range: NR

100 % female

Ethnicity: NR
History of PONV: 73.2%

History of motion sickness: 37.4%

Current daily smokers: 22.9%
NR/NR/20021/NR/179Patient satisfaction (score: 0–10 “most satisfied”)
A: 9 (range: 0–10)
B: 9 (range: 0--10)
C: 10 (range: 0–10), p =0.001 when C compared with B
NR
Khalil
1999
Single Center
US
RCT, ACT
DB
Elective middle ear surgery

All pts had stomach contents aspirated at end of operation

Duration of anesthesia: 204.5min
Duration of surgery: 152.7 min
Non-obese and non-mentally retarded adult ASA I and II ptsA: Ond 4mg
B: Promethazine (Prom) 25mg
C: Ond 2mg + Prom 25mg
D: placebo
Pre-medication with midazolam 2 mg ivNR/NRMean age:
Range: 13–72 y

47.1% female

Ethnicity: NR
History of PONV: 21.8%

History of motion sickness: 8.0%
NR/NR/87NR/NR/87Patient Satisfaction Score (0: “very dissatisfied” to 10: “very satisfied”): 9.1 vs 8.8 vs 9.2 vs 8.7; NSDuration of PACU stay (min): 94 vs 87 vs 89 vs 95; NS
Pan
2008
Two Sites
US
RCT, DBLaparoscopic gynecological surgeriesASA I–II patients undergoing outpatient laparoscopic gynecological surgeries with general anesthesia; aged ≥18years; having all three patient specific emetic risk factors; ability to follow study protocol instructions; and willing to complete the daily diaryStudy group: IV dexamethasone 8mg in 2mL volume after successful intubation, and IV ondansetron 4mg within 15min before tracheal extubation at the end of anesthesia, then ODT of ondansetron 8mg at the time of discharge from PACU and on the morning of postoperative day 1 and 2 at home.

Control group: IV placebo of 2mL normal saline after successful intubation, and IV ondansetron 4mg within 15min before tracheal extubation at end of anesthesia, then placebo ODT at discharge and on the morning of postoperative day 1 and 2 at home.
Preoperative medication consisted of 0–2mg iv midazolam and oral ibuprofen 800mg

1st rescue medication was promethazine 25–50mg iv
NR/NRMean age: 34.5 years
100% female
Ethnicity NR
Mean weight (kg): 80
Mean height (cm): 163.5
64/60/60NR/NR/60Overall satisfaction score (0–10)
Study group: 9.6 vs Control group: 8.8
Patients most/very satisfied with antiemetic regimen
Study group: 87% vs Control group: 83%
Study group vs Control group
Patients reporting nausea affecting QOL: 33% vs 60% (p<0.04)
Patients reporting emesis affecting QOL: 3% vs 20% (p<0.04)
Cumulative modified FLIE scores for nausea: 15.2 vs 23.8 (p<0.02)
Cumulative modified FLIE scores for emesis: 9.3 vs 14 (p<0.04)
Purhonen
2006 (B)
NR
RCT,Breast surgeryASA I–III females aged 18–75 yrs scheduled to undergo breast surgery (partial or radical mastectomy, breast reconstruction, or both)A:30% oxygen in nitrogen and saline 2 ml i.v.
B:80% oxygen in nitrogen and saline 2 ml i.v.
C:30% oxygen in nitrogen and ondansetron 4 mg i.v.
All received oral diazepam 0.15–.02 mg/kg

Rescue medication was permitted (droperidol 1.25 mg iv for 1st use, dexamethasone 5mg iv for 2nd use, and ondansetron 4mg iv for 3rd use)
NR/No antiemetics, antihistaminics within 24 hours before surgeryMean age: 53.33 yrs
Range: 18–75 yrs

100% female
Ethnicity: NR
BMI: 24.3
History of previous PONV: 30.5%
History of motion sickness: 36.4%
Nonsmokers: 87%
Duration of anesthesia (min): 128
Duration of surgery (min): 99
Type of surgery
Mastectomy (partial or radical): 68%
Mastectomy and breast reconstruction:
12%
Breast reconstruction: 20%
NR/NR/905/NR/85Would choose same treatment for future surgery
30O2: 79% vs 80O2: 76% vs Ond: 89%
Would choose a different treatment for future surgery
30O2: 7%% vs 80O2: 7% vs Ond: 4%
Time from end of surgery to 1st rescue medication use (min)
30O2: 341 vs 80O2: 266 vs Ond: 344
Incidence of 2nd rescue medication use
30O2: 14.3% vs 80O2: 24.1% vs Ond: 7.1%
Incidence of 3rd rescue medication use
30O2: 3.6% vs 80O2: 13.8% vs Ond: 0%
Time to tolerate fluids (min)
30O2: 382 vs 80O2: 452 vs Ond: 403
Time to tolerate food (min)
30O2: 816 vs 80O2: 919 vs Ond: 701 (p<0.05 for 30O2 vs 80O2)
Reihner
1999
Single Center
Sweden
RCT, ACT
DB
Breast surgery

Mean anesth. duration: 101.7 min
Non-pregnant, non-obese ASA
I or II women
A: Ond 8 mg iv

B: droperidol (drop) 1.25 mg iv

C:placebo
Premedication of all pts with midazolam 4 mg <60kg and 5 mg >60kg imNR/NRMean age: 54y
Range: 18–80 y

100% female

Ethnicity: NR
History of PONV: 43.5%

History of motion sickness: 21.7%

menstrual group (cycle day 1–8): 7.7%
NR/NR/2169/NR/207NRStay in PACU (min): 120 vs 120 vs 120, NS
Sandhu
1999
NR
RCT, PCT
DB
Elective gynecologic laparoscopy with std anesthesia (w/o gastric suctioning)

surgery duration: 25.0 min
Anesthesia duration: 33.1 min
ASA I–II womenA: Ond 8 mg iv
B: Dimenhydrinate 50 mg iv
C: Placebo
NRNR/NRMean age: 32.7 y
Range: NR

100% female

Ethnicity: NR
NR/NR/87NR/NR/87Overall satisfaction score (0 – 10 “satisfied”):
PACU: 9 vs 9 vs 9; NS
Home: 8 vs 8 vs 8, NS
Mean time to discharge (min): 189 vs 199 vs 205, NS
Steinbrook
1996
Single Center
US
RCT, DB
semi- crossover(see intervention)
Laproscopic cholecystectomy
Mean surgery time: 77.4 min
pts scheduled for laproscopic cholecystectomyA: Drop 0.625 mg iv + metoclopramide 10 mg
B: Ond 4 mg + saline

Moderate or severe nausea or vomiting in PACU was treated with the cross-over drug
Premedication of all pts with midazolam 1–2 mg ivNRMean age: 43.5 y
Range: NR

86% female

Ethnicity: NR
NR/NR/21515/NR/200NRDischarge time (min): 293 vs 288, NS
Adults: Placebo- controlled trials
Dolasetron
Diemunsch
1997
multicenter
Europe
RCT, PCT
DB
Pts undergoing surgery with general anesth.

Gyn. surgery: 63.2%

Anesth. duration: 1.73 h
Non-pregnant, Dol naïve ASA I or II pts with no alcohol or drug addiction and normal serum Na and K concentrations before surgeryA: Dol 12.5 po
B: Dol 25 po
C: Dol 50 po
D: Dol 100 po
F: placebo
NoNR/no drugs with antiemetic properties allowed 24h before surgeryMean Age: 40.4 y
Range: 18–65y

94.7% female

Ethnicity: NR
History of PONV: 45.8%

History of motion sickness: NR
NR/NR/337NR/0/337Patient satisfaction (VAS score: 0 = not at all satisfied to 100 = complete satisfaction)

VAS scores not given; the only thing said was that Dol-treated pts were more satisfied with treatment than placebo pts (p<0.003)
NR
Diemunsch
1998
multicenter
Europe
RCT, PCT
DB
Patients undergoing major gynecologic
surgery: 100%

Anesth. Duration: 1.6 hrs
Female patients with ASA physical status I, II and III between 18–60 yrs, weighing 45– 100kgA: Dol 25 mg po
B: Dol 50 mg po
C: Dol 100 mg po
D: Dol 200 mg po
E: Placebo
Intramascular or IV morphine and/or NSAIDS were used as postoperative analgesiaNR/NRMean age: 43 yrs
100% female
White: 96%
Black: 1.1%
Other: 3.4%
ASA physical status I: 75%
mean weight: 68 kg
mean height: 163 cm
History of PONV: 32%
History of motion sickness: 18%
NR/NR/7934/NR/789Patient satisfaction VAS scores: 0 mm= not at all satisfied, 100=as satisfied as a pt could be)
A: 84.5 mm (p=0.004 vs placebo)
B: 97.0 mm (p=<0.001)
C: 97.0 mm (p<0.001)
D: 96.0 mm (<0.001)
Proportion of patients requiring rescue medication:
A: 37%
B: 31% (p=0.0011 vs placebo)
C: 34%
D: 37%
E: 48%
Warriner
1997
Multicenter
Canada
RCT, PCT
DB
Total abdominal hysterectomy (TAH) (100%)

Anesth. duration: 1.5 h
non-pregnant ASA I or II women under gen. anesthesia undergoing TAHA: Dol 25 po
B: Dol 50 po
C: Dol 100 po
D: Dol 200 po
F: placebo
1 mg lorazepam po or sl the night prior to surgeryNR/no drugs with antiemetic properties allowed 24h before surgeryMean Age: 43.4
Range: 18–70

100% female

White: 81.9%
Black: 4%
Asian: 10.4%
Other: 3.7%
History of PONV: 46.8%
History of motion sickness: 27.5%
NR/NR/3741/0/373Patient satisfaction (VAS score: 0 = not at all satisfied and 100 = as satisfied as pt could be)

A: 91.0 (p<0.05 vs placebo)
B: 89.8
C: 91.0 (p<0.05 vs placebo)
D: 85.0
E: 79.0
NR
Granisetron
Ondansetron
Cherian
2001
Single center
UK
RCT, PCT
DB
Elective Caesarian section under spinal subarachnoid blockPregnant women without pre- eclampsiaA: Ond 4 mg iv at end of surgery + 8 mg added to PCA morphine syringe

B: nothing in surgery + no Ond in PCA morhpine syringe (placebo group)
NRNR/NRNRNRNR/NR/81NR/NR/81Overall satisfaction with care (% pts):

Good : A: 85%, B: 87.5%
Moderate : A: 12%, B: 10%
Poor : A: 3%, B: 2.5%
p = NS between A & B
NR
Han
2004
Single center
Korea
RCT, PCT
DB
elective surgery under gen. anesth.

Mean duration of anesth: 163.5 min
Male smoking pts ≥ 61y without a history of PONV, motion sickness, or migraineA: Ond 4 mg iv
B: placebo
15 min before anesth. ended

A: Ond 16 mg placed in PAC pump
B: placebo in PAC pump
NRNR/NRMean age: 67.6 y
Range: ≥ 61 y

0% female

Ethnicity: NR
Hip surgery: 49%
Knee surgery: 22.8%
NR/ NR/ 37424/ NR/ 350Pt satisfaction for analgesia therapy, A vs. B, p = NS for all:
“very satisfied”: 39.9% vs 42.9%
“satisfied”: 38.1% vs 38.4%
“neither dissatisfied nor satisfied”: 18.5% vs 15.8%
“Dissatisfied”: 3.5% vs 2.8%
Lekprasert
1996
Single center
Thailand
RCT, PCT
DB
gastrointestinal surgery (laproscopic cholecystectomy (50%), open cholecystectomy (40.2%), appendectomy (7.3%), etc) with general anesth.

80.5% of pts had surgery lasting <2 hrs; 44% had gastric suctioning
ASA I or II status non-pregnant non-drug abusing pts; if women they had to be <100kg and if men <120kgA: Ond 4 mg iv, prior to induction
B: placebo iv
Some premedicated with benzodiazepines (excluding lorazepam) prior to surgery or at inductionNR/ no drugs with antiemetic properties allowed 24h before surgeryMean age: 50.1y
Range: 12–75y

74.4% female

Ethnicity; NR
Opioid use, A vs B: 51.2% vs 80.4%NR/ NR/ 82NR/ NR/ 82Patient Satisfaction levels (p = NS for all comparisons):
most satisfied, A vs B: 4.87% vs 21.95%
Satisfied, A vs B: 70.73% vs 58.54%
Undecided, A vs B: 19.51% vs 17.07%
Unsatisfied, A vs. B: 4.87% vs 2.44%
Most unsatisfied, A vs B: 0% vs 0%
NR
Purhonen
2006 (A)
NR
RCT, PCT
DB
Gynecologic laparoscopyASA I or II female patients scheduled to undergo gynecologic laparoscopyA: Preoperative placebo tablet, propofol induction, propofol-air/O2 maintenance
B: Preoperative 8-mg Ond tablet, thiopentone induction, isoflurane- N2O maintenance
C:Preoperative placebo tablet, thiopentone induction, isoflurane- N2O maintenance
Fentanyl 1 μg/kg iv or oxycodone for postoperative pain

Metoclopramide 10mg iv for rescue medication was permitted
NR/No antiemetics 24 hours before surgeryMean age: 34.35 yrs
100% females
Ethnicity: NR
Mean weight (kg): 64
Mean height (cm): 164.6
History of PONV: 28.6%
History of motion sickness: 42%
Nonsmoking status: 81.3%
NR/NR/150NR/NR/150NRMedian cost of anesthetic drugs
Prop: $31 vs Ond: $35 vs Pla: $18
Readiness for ward transfer (min)
Prop: 61 vs Ond: 90 vs Pla: 64 (p<0.05 for Prop vs Ond)
Time to tolerate intake of oral fluids (h)
Prop: 3 vs Ond: 3 vs Pla: 3
Time to tolerate intake of food (h)
Prop: 6 vs Ond: 6 vs Pla: 7
Time to Walking (h)
Prop: 5.8 vs Ond: 6.5 vs Pla: 7.5
Sadhasivam
1999
Single center
India
RCT, PCT
DB
Modified radical mastectomy

Mean anesth. duration: 152 min
ASA I or II non-obese ptsA: Ond 4 mg iv
B: placebo
at end of surgery
All pts received diazepam 0.2 mg/kg po the night before surgery and 2h before inductionNR/ no drugs with antiemetic properties allowed 24h before surgeryMean age: 45.7 y
Range: NR

100% female

Ethnicity: NR
History of PONV: 5.6%

History of motion sickness: 18.5%
NR/ NR/ 54NR/ NR/ 54Pt satisfaction scores:
(0 = “not satisfied” to 10 = “fully satisfied”)
Ond vs Plac: 8.1 vs 6.1, p = 0.0000
Scuderi
1999
Single-center
US
RCT, PCT
DB
Outpatient surgery with general anesthesiaASA I, II, or III outpatientsA: Ond 4 mg iv
B: placebo
Premedication with midazolam: 98.8%NR/ NRMean age: 38.2 y
Range: 18–65 y

63.3% female

White: 80%
African American: 18.9%
Other: 0.1%
History of risk factors: 58.4%NR/ NR/ 575Satisfaction with control of PONV: #yes/#no, A vs B:
230/7 (97%) vs 212/16 (93%), p = 0.04
Time to discharge from PACU to day hospital (min): 59 vs 58, NS,
Time to discharge from PACU to home (min): 87 vs 92, NS
Sun
1997
RCT, PCT
DB
ambulatory otolaryngologic procedures (sinus surgery (70.7%), and others)
anesth. duration: 93.3 min
Non-pregnant, non-obese non- drug using ASA I or II ptsA: Ond 4 mg iv before induction of anest. + placebo at end of procedure
B: placebo at induction + Ond 4 mg iv at end
C:placebo + placebo
Premedication of all pts with midazolam 0.02 mg/kg ivNR/ no drugs with antiemetic properties allowed 24h before surgeryMean age:
Range: 20–70y

46.7% female

Ethnicity: NR
History of PONV: 22.7%

History of motion sickness: 26.7%
NR/ NR/ 75NR/ NR/ 75NRPACU recovery times (min): 73 vs 63 vs 66, NS
Hospital discharge times (min): 225 vs 188 vs 203, NS
Tang
1998
US
RCT, PCT
DB
Outpatient laproscopic procedures

Duration of anesth. : 79.2 min
ASA I or II non-pregnant, non- obese female ptsA: Ond 2 mg iv pre-induction + Ond 2 mg at end of operation
B: Ond 4 mg iv pre-induction + placebo at end
C: placebo pre-induction + Ond 4 mg iv at end
D: placebo + placebo
Premedication of all pts with midazolam 2 mg ivNR/ no drugs with antiemetic properties allowed 24h before surgeryMean age: 37.7 y
Range: 20–70y

100% female

Ethnicity: NR
History of PONV: 30.1%

History of motion sickness: 35.2%

Last menstrual period: 0–8 days previously: 26.3%
NR/ NR/ 1648/ NR/ 156Highly satisfied (% pts): 38 vs 36 vs 37 vs 37, NS*=p<0.05 vs placebo
Discharge-ready (min): 198 vs 180 vs 168* vs 213
Actual discharge (min): 234 vs 207 vs 198* vs 243*
Caretaker needed (days): 0.9 vs 0.3 vs 0.8 vs 0.8, NS
Return to work (days): 4.5 vs 4.5 vs 4.4 vs 5.6, NS
Thagaard
2003
Single Center
Norway
RCT, PCT
DB
Elective laproscopy for fundoplication (41%) or cholecystectomy (54%)

Mean duration of surgery: 100 min
ASA 1 or II ptsA: Ond 8 mg orally disintegrating tablets bid starting the night after surgery
B: placebo
Pre-medication with midazolam 1–2 mg iv; all pts received droperidol
0.1235mg and Ond 4 mg iv prior to emergence from anesthesia

Pain medication after surgery: codeine 60 mg+paracetamol 1000mg up to 4X/day
Ond 4 mg iv prior to end of anesthesiaMean age: 43.1 y
Range: ≥ 18 y

68.7% female

Ethnicity: NR
History of PONV: 10.3%

History of motion sickness: 40.6%
NR/ NR/ 1026/ NR/ 96Acute: (4–24h post-op):
Overall satisfaction compared with expectation: worse/ similar/ better:
41/ 36/ 23 vs 35/ 42/ 23, p=NS
Delayed (24–72 h post op):
Overall satisfaction compared with expectation: worse/ similar/ better:
29/ 47/ 24 vs 16/ 51/ 33, p = NS
Acute: (4–24h post-op):
Time to discharge ready (min): 299 vs 277, p=NS
Pt rating of general function (1 “all time in bed” to 5 “full normal activity”):
2.4 vs 2.4, p = NS
Delayed (24–72 h post op):
Pt rating of general function (1 “all time in bed” to 5 “full normal activity”):
3.1 vs 3.2, p = NS
Trescha
2005
Single Center
Germany
RCT, DBStrabismusASA I or II pts scheduled to undergo strabismus surgeryA: 30% inspired oxygen in air plus intravenous administration of saline

B: 80% inspired oxygen in air plus intravenous administration of saline

C:30% inspired oxygen in air plus 75 μg/kgondansetron intravenously during induction
Pre-medicated with midazolam

Paracetamol 20 μg/kg for analgesia

Rescue medication of dimenhydrinate (1–3 mg/kg) permitted
NR/NRMean age: 30.65
Range: 5–79 yrs

% female: 55.24%
Ethnicity: NR
Pediatric patients (aged <15 years): 31.4%
Mean weight (kg): 60.6
Mean height (cm): 160
Duration of surgery (min): 27.3
Current smokers: 30%
History of motion sickness: 17.6%
History of PONV: 20.5%
373/318/210NR/NR/210No difference in patient satisfaction (numbers NR)30O2 vs 80O2 vs OND
Use of rescue therapy 0–24h after surgery: 15% vs 12% vs 7%
Use of rescue therapy 0–6h after surgery: 10% vs 9% vs 6%
Use of rescue therapy 6–24h after surgery: 10% vs 4% vs 1%
Palonosetron
Candiotti
2008
Multiple Sites
USA
RCT, DBAbdominal or gynecological surgeryASA I–III patients scheduled to undergo elective laparoscopic abdominal or gynecological surgery of at least 1 hour duration.A: Palonosetron 0.025mg

B: Palonosetron 0.050mg

C: Palonosetron 0.075mg

D: Placebo
Rescue medication was permitted at the discretion of the investigatorNR/NRMean age: 37.75
Range: 18–77 years
96% female
Ethnicity NR
History of PONV: 64.5%
Non-Smoker: 85.2%
Mean BMI: 26.75
Gynecological surgery: 74.5%
Abdominal surgery: 25.5%
639/574/54748/NR/547NRPalonosetron 0.075mg vs Placebo
Percentage of patients without functional interference during 0–24h postoperative period
Appetite: 44% vs 57% (p=0.018)
Sleep: 64% vs 73%
Physical activities: 59% vs 65%
Social life: 62% vs 73% (p=0.13)
Enjoyment of life: 57% vs 66% (p=0.096)
RS-25259
Tang
1998
Two Sites
US
RCT, DB,
PCT
HysterectomyASA I or II pts undergoing abdominal or vaginal hysterectomy with general anesthetic techniqueA: RS-25259 0.1 μg/kg
B: RS-25259 0.3 μg/kg
C: RS-25259 1.0 μg/kg
D: RS-25259 3.0 μg/kg
E: RS-25259 30 μg/kg
F: Placebo
Midazolam 2mg iv was used to premedicate all patients.
Rescue medication was permitted
NR/No use of antagonists,antiemetic or psychoactive medications within 24 hours before operationMean age: 41 y
100% female
Ethnicity: NR
Mean weight (kg): 72.3
Previous PONV: 36.6%
Previous motion sickness: 11.5%
NR/NR/218NR/NR/218Data not presented, however, statement of “The overall satisfaction with the control of PONV in the first 24 hours after surgery was also similar.”A vs B vs C vs D vs E vs F
Use of rescue medication 0–2h after surgery: 22% vs 22% vs 23% vs 20% vs 23% vs 31%
Use of rescue medication 0–12h after surgery: 63% vs 56% vs 43% vs 43% vs 46% vs 72% (p<0.05 for C vs F; D vs F; and E vs F)
Use of rescue medication 0–24h after surgery: 67% vs 61% vs 54% vs 53% vs 49% vs 75% (p<0.05 for E vs F)
Time to first rescue medication use (min): 314 vs 326 vs 381 vs 430 vs 474 vs 234
Use of rescue medication 0–2h after surgery for those with history of PONV: 33% vs 29% vs 46% vs 20% vs 33% vs 29%
Use of rescue medication 0–12h after surgery for those with history of PONV: 75% vs 79% vs 62% vs 47% vs 67% vs 79%
Use of rescue medication 0–24h after surgery for those with history of PONV: 75% vs 86% vs 62% vs 67% vs 67% vs 79%
Use of rescue medication 0–2h after surgery for those with NO history of PONV: 13% vs 19% vs 6% vs 20% vs 19% vs 32%
Use of rescue medication 0–12h after surgery for those with NO history of PONV: 53% vs 44% vs 32% vs 40% vs 37% vs 68% (p<0.05 for C vs F and E vs F)
Use of rescue medication 0–24h after surgery for those w
Children: Active- controlled trials
Ondansetron
Bach-Styles
1997
Single Center
US
RCT, ACT
DB
Pediatric pts undergoing opthamalic surgery

Anesth. duration: NR
Pediatric pts ASA status I, II, or IIIA: Ondansetron (Ond) 0.15 mg/kg iv
B: Metoclopramide (Met) 0.25 mg/kg iv
C: placebo
NRNR/NRMean Age: NR
Range: 1–17 y

94.7% female

Ethnicity: NR
“ANOVA showed no significant difference between the 3 study groups with regard to Age, height, weight, ASA status, history of vomiting, no. of muscles repaired, iv fluids, or duration of surgery.” this statement were given. No specifics other thanNR/NR/52NR/NR/52Satisfaction (% parents): 94% vs 74% vs 74%, NSHospital stay (# min): 132 vs 137 vs 132, NS
Davis, A.
1995
Single Center
Saudi Arabia
RCT, ACT
DB
Elective strabismus repair surgery w/o gastric suctioning
Mean surgery time: 87 min
ASA I or II pediatric and adult ptsA: Ond 75 mcg/kg
B: Ond 150 mcg/kg
C: Droperidol 75 mcg/kg
Premedication: midazolam 0.5 mg/kg po (Max 10 mg) for children and 5–10 mg diazepam po for adultsNR/NRMean age: 12.4 y
Range: NR

39.4% female

Ethnicity: NR
NR/NR/213NR/NR/213NRMean discharge times from recovery (min): 44.4 vs 75.3 vs 41, NS
Davis, P.
1995
Single Center
US
RCT
DB
Dental surgery (with stomach suctioning at end)ASA I and II pediatric ptsA: Ond 100 mcg/kg iv
B: Droperidol (drop) 75 mcg/kg iv
C: placebo
All pts premedicated with either midazolam intranasally (0.2–0.3 mg/kg, max = 5 mg) or po (0.5 mg/kg, max 15 mg)NR/NRMean age: 42.7 mos
Range: 2–8 yrs

% female: NR

Ethnicity: NR
NR/NR/1027/NR/95NRPACU length of stay (min): 28.6 vs 39.9 vs 29, NS
Hospital length of stay (min): 74 vs 106 vs 85; O>D, p<0.05
Litman
1995
Multicenter
US
RCT, ACT
DB
Strabismus repair

Mean anesthesia time: 81.6 min
healthy ASA I and II children without a history of gastric motility disordersA: Ond 0.15 mg/kg iv
B: Droperidol 0.075 mg/kg iv
If needed, pts premedicated with midazolam 0.5 mg/kg poNR/NRMean age: 5.75 y
Range: 3–14yrs

40.3% female

Ethnicity: NR
NR/NR/57NR/NR/57NRDuration of PACU stay (min): 46.2 vs 54.6, NS
Time to discharge (min): 235 vs 258, NS
Rose
1994
Single Center
US
RCT, ACT
DB
Strabismus repairASA I and II
pediatric/adolescent pts
A: Ond 0.15 mg/kg iv
B: Metoclopramide (meto) 0.25 mg/kg iv
C: placebo
All received midazolam 0.5 mg/kg po (max 20 mg) but one who got midazolam 0.2 mg/kg intranasally and one who received diazepam 0.1 mg/kg poNR/NRMean age: 72 mos
Range: 2–17 y

48.9% female

Ethnicity: NR
NR/NR/90NR/NR/90NRTime until discharge (min): 111 vs 124 vs 127, NS
Splinter
1998
Single Center
Canada
RCT, ACT
DB
Elective tonsillectomy or adenotonsillectomyhealthy children with ASA I or II status and no sleep apnea

Anesth. duration: 31.5 min
A: Ond 150 mcg/kg (max 8 mg) iv
B: Perphenazine (perp) 70 mcg/kg
iv (max 5 mg)
Pts received either midazolam 0.5mg/kg (max 15 mg) po before induction or Midazolam 50 mcg/kg (max 3 mg) iv during surgery

All received codeine 1.5 mg/kg im
NR/NRMean age: 6.9 y
Range: 2–12 y

54.6% female

Ethnicity: NR
NR/NR/2204/NR/216NRMean duration of stay in PAR (min): 46 vs 47, NS
Duration of stay in day-case surgical unit (median min):
235 vs 240, p=0.007
Stene
1996
Single center
US
RCT, ACT
DB
Tonsillectomy (92.5%) or adenotonsillectomy (7.5%)ASA I and II pediatric ptsA: Ond 0.15 mg/kg iv
B: Metoclopramide 0.25 mg/kg iv
C: placebo
No predication besides oral atropine allowedNR/NRMean age:6.0 yrs
Range: 2– 12 y

% female: NR

Ethnicity: NR
NR/NR/13212/NR/120NRLength of stay (min): 449 vs 485 vs 481, NS
n=100 (75.7% of randomized) (study rated poor)
Granisetron
Luisi
2006
Brazil
University Hospital
RCT, DBN/APatients <20years, with a diagnosis of mestastic or non- mestastic osteosarcoma, who are undergoing chemotherapy treatment in a day hospitalA: Granisetron 50μg/kg

B: Metoclopramide 2mg/kg + dimenhydrinate 5mg/kg infusion
NRNR/NRMean age: 14 y
Range: 7–19 y
42.3% female
Ethnicity: NR
NRNR/NR/26NR/NR/26NROverall Efficacy (Modified MANE scale)
Complete: Met: 10% vs Gran: 62.5% (p<0.0001)
Partial: Met: 35% vs Gran: 32.5%
Minimum: Met: 42.5% vs Gran: 5%
Absence: Met: 12.5% vs Gran: 0%
Children: Placebo- controlled trials
Granisetron
Carnahan
1997
Single center
US
RCT, PCT
DB
Tonsillectomy and adenoidectomy (T & A); pts had gastric suctioning during surgeryPediatric pts of ASA I or II undergoing elective outpt T & AA: Gran 0.01 mg/kg iv
B: placebo
Midazolam 0.5 mg/kg up to 10mg was given 15–30 min before inductionNR/NRMean age: 4.87 y
Range: 2–8 y
48.1% female
White: 81.5%
Black: 11.1%
Other: 7.4%
NRNR/NR/54NR/ NR/ 54NRPt discharge time:

A: 250.0 (+/− 147.27) min (p<0.05)
B: 320.8 (+/−118.22) min
Cieslack
1996
Single center
US
RCT, PCT
DB
Outpatient strabismus correction (42.3%), tonsillo-adenoidectomy (19.6%), or dental surgery (34%) using endotracheal gen. anesth. with end-of- surgery stomach suctioning
Mean duration of anesth. = 80.5 min
ASA I and II children who had not recently received an drug with an antiemetic effectA: Gran 10 mcg/kg iv
B: Gran 40 mcg/kg iv
C: Placebo
All pts received midazolam 0.5 mg/kg 15–30 min before inductionNR/NRMean age: 5.2 y
Range: 2–16 y
48.4% female
Ethnicity: NR
NR/NR/97NR/ NR/ 97Mean global parental satisfaction score (0= not at all satisfied; 10=fully satisfied), and % of parents giving a score >8:
A: 9.3, 93% score>8
B: 9.1, 97% score>8
C: 8.8, 81%, score>8, p=NS for all comparisons
Discharge readiness (min): 129 vs 108 vs 152
G 10 mg>placebo, p<0.05; otherwise NS
Munro
1999
Single-center
US
RCT, PCT
DB
Strabismus repair surgery with stomach suctioning at end

Anesth. duration: 69.6 min
ASA I–II out-patient pediatric ptsA: Gran 20 mcg/kg suspension
B: Gran 40 mcg/kg suspension
C: placebo
NoNR/no drugs with antiemetic properties allowed prior to surgeryMean age: 5.0 y
Range: 1–12 y
53.4% female
Ethnicity: NR
NR/NR/763/ NR/ 73NRTime to discharge readiness (min): 104.8, vs 104.7 vs 124, p<0.05 for both G groups vs placebo
Patel
1997
multicenter
US
RCT, PCT
DB
Outpt surgeries with gastric suctioning: stabismus surgery (33.8%), tonsillectomy w/or w/o andenoidectomy (26.1%), herniorrhaphy (31.9%), or orchidopexy (7.9%)

Mean duration of anesth.: 57.2 min
ASA I–III pediatric pts without liver or renal disease or vomiting within 24h before surgeryA: Ond 0.1 mg/kg iv if child ≤ 40kg; 4 mg if child >40kg
B:placebo
premedication left up to MDNR/no drugs with antiemetic properties allowed within 24h of surgeryMean age: 5.3y
Range: 2–12y
36.8% female
Caucasian: 77.8%
African American: 13.7%
Hispanic: 4.0%
Asian: 2.1%
Other: 2.3%
Previous history of motion sickness: 8.9%

Previous PONV: 6.5%
NR/NR/4334/ NR/ 429NRMean time to reach home-readiness (min): 155.7 vs 183.2, p<0.05
Mean time between responsiveness to spoken command until discharge from facility (min): 175.6 vs 214.8, p<0.05
Ondansetron
Sennaraj
2002
NR
NR
RCT, DBStrabismus repair under gen. anesthesia

Mean anesth. duration: 64.15 min
ASA I or II children who had not received drugs with antiemetic properties within 24h of the studyA: Ond 100 mcg/kg iv at end of procedure + Ond 100 mcg/kg at first signs of PONV (prophylactic)

B: placebo at end of procedure + Ond 100 mcg/kg at first signs of PONV (therapeutic)
NoNR/ no drugs with antiemetic properties allowed 24h before surgeryMean age: 6.6 y
Range: 2–15 y

58.7% female

Ethnicity: NR
Prior PONV: 28%NR/ NR/ 150NR/ NR/ 150Parental satisfaction score (0= not at all satisfied; 10=fully satisfied): 8.2 vs 6.8, p<0.0001Mean PACU stay (min): 126.5 vs 141.1, p=0.0002

From: Evidence Tables

Cover of Drug Class Review: Newer Antiemetics
Drug Class Review: Newer Antiemetics: Final Report Update 1 [Internet].
Peterson K, McDonagh M, Carson S, et al.
Portland (OR): Oregon Health & Science University; 2009 Jan.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.