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Paediatric Anaesthesia 1997 7: 37–45 Ondansetron reduces nausea and vomiting after paediatric adenotonsillectomy N.S. MORTON MBCHB, FRCA*, F. CAMU MD², T. DORMAN MBCHB, FFARCS, FRCA‡, K.E. KNUDSEN MD§, O. KVALSVIK MD¶, P. NELLGARD MD||, C.P. SAINT-MAURICE MD**, W. WILHELM MD, DEAA²² AND L.A. COHEN BPHARM, MSc‡‡ * Department of Paediatric Anaesthesia and Intensive Care, Royal Hospital for Sick Children, Yorkhill NHS Trust, Glasgow G3 8SJ, Scotland, UK ² Department of Anesthesia, Flemish Free University of Brussels, Laarbeeklan 101, 1090 Brussels, Belgium Department of Anaesthetics, Sheffield Children’s Hospital, Western Bank, Sheffield S10 2TH § Bispebjerg Hospital, Bispebjerg Bakke, 2400 København NV, Denmark Department of Anaesthetics, Regionsykehuset i Trondheim, 7001 Trondheim, Norway || Anestesidivisionen sektion III, Sahlgrenska sjukhuset, 413 45 Go ¨teborg, Sweden ** De ´partment d’anesthe ´siologie, Ho ˆpital Saint Vincent de Paul, 74/82 avenue Denfert-Rochereau, 75674 Paris Cedex 14, France ²² Klinik fu ¨ r Anaesthesiologie und Intensivmedizin, Universita ¨tskliniken des Saarlandes, Oscar-Orth-Straße, 66421 Homburg/Saar, Germany ‡‡ Gastrointestinal Clinical Research Department, Glaxo Research and Development Limited, Greenford Road, Greenford, Middlesex UB6 0HE, UK Summary The efficacy, safety and resource implications of a single intravenous dose of ondansetron (0.1 mg·kg -1 , maximum 4 mg) were assessed in a multinational, multicentre, randomized, double-blind, placebo- controlled trial of 427 children aged 1–12 years, undergoing tonsillectomy with/without adenoidectomy. Emesis (retching and/or vomiting) and nausea were analysed separately. Significantly more ondansetron-treated children had no episodes of emesis (127/212 (60%) vs 100/215 (47%); P=0.004) and experienced no postoperative nausea (135/211 (64%) vs 108/213 (51%); P=0.004) in the first 24 h. Ondansetron also reduced the number of emetic episodes (P<0.001), the time to the first emetic episode (P<0.001) and overall nausea severity (P=0.003). Significantly fewer ondansetron-treated children were rescued or withdrawn from the study (5% vs 10%; P=0.042). Fewer ondansetron-treated patients required nursing intervention (34% vs 45%; P=0.007) and the average intervention time was significantly shorter (4.6 vs 8.1 minutes; P=0.001). Resources used to manage PONV were significantly reduced by ondansetron (43% vs 57%; P=0.014). Keywords: ondansetron; adentonsillectomy; vomiting; nausea Introduction nausea and vomiting (PONV), with the highest incidence occurring after strabismus surgery (1), Although paediatric adenotonsillectomy is associated antiemetics are not routinely used because of the with the second highest incidence of postoperative relatively high incidence of drug related adverse effects in younger patients (2). The selective 5-HT 3 receptor antagonist ondansetron has been shown to Correspondence to: N.S. Morton, Department of Paediatric be effective and well tolerated in adults and children Anaesthesia and Intensive Care, Royal Hospital for Sick Children, Yorkhill NHS Trust, Glasgow G3 8SJ, Scotland, UK. for the prevention and treatment of nausea and 37 1997 Arnette Blackwell SA

Ondansetron reduces nausea and vomiting after paediatric adenotonsillectomy

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Page 1: Ondansetron reduces nausea and vomiting after paediatric adenotonsillectomy

Paediatric Anaesthesia 1997 7: 37–45

Ondansetron reduces nausea and vomiting afterpaediatric adenotonsillectomy

N.S. MORTON MBCHB, FRCA∗, F. CAMU MD†, T. DORMAN MBCHB,

FFARCS, FRCA‡, K.E. KNUDSEN MD§, O. KVALSVIK MD¶,P. NELLGARD MD||, C.P. SAINT-MAURICE MD∗∗,W. WILHELM MD, DEAA†† AND L.A. COHEN BPHARM, MSc‡‡∗Department of Paediatric Anaesthesia and Intensive Care, Royal Hospital for Sick Children,Yorkhill NHS Trust, Glasgow G3 8SJ, Scotland, UK† Department of Anesthesia, Flemish Free University of Brussels, Laarbeeklan 101,1090 Brussels, Belgium‡ Department of Anaesthetics, Sheffield Children’s Hospital, Western Bank, Sheffield S10 2TH§ Bispebjerg Hospital, Bispebjerg Bakke, 2400 København NV, Denmark¶ Department of Anaesthetics, Regionsykehuset i Trondheim, 7001 Trondheim, Norway|| Anestesidivisionen sektion III, Sahlgrenska sjukhuset, 413 45 Goteborg, Sweden∗∗Department d’anesthesiologie, Hopital Saint Vincent de Paul,74/82 avenue Denfert-Rochereau, 75674 Paris Cedex 14, France†† Klinik fur Anaesthesiologie und Intensivmedizin, Universitatskliniken des Saarlandes,Oscar-Orth-Straße, 66421 Homburg/Saar, Germany‡‡ Gastrointestinal Clinical Research Department, Glaxo Research and Development Limited,Greenford Road, Greenford, Middlesex UB6 0HE, UK

SummaryThe efficacy, safety and resource implications of a single intravenousdose of ondansetron (0.1 mg·kg−1, maximum 4 mg) were assessedin a multinational, multicentre, randomized, double-blind, placebo-controlled trial of 427 children aged 1–12 years, undergoingtonsillectomy with/without adenoidectomy. Emesis (retching and/orvomiting) and nausea were analysed separately. Significantly moreondansetron-treated children had no episodes of emesis (127/212 (60%)vs 100/215 (47%); P=0.004) and experienced no postoperative nausea(135/211 (64%) vs 108/213 (51%); P=0.004) in the first 24 h.Ondansetron also reduced the number of emetic episodes (P<0.001), thetime to the first emetic episode (P<0.001) and overall nausea severity(P=0.003). Significantly fewer ondansetron-treated children wererescued or withdrawn from the study (5% vs 10%; P=0.042). Fewerondansetron-treated patients required nursing intervention (34% vs 45%;P=0.007) and the average intervention time was significantly shorter(4.6 vs 8.1 minutes; P=0.001). Resources used to manage PONV weresignificantly reduced by ondansetron (43% vs 57%; P=0.014).

Keywords: ondansetron; adentonsillectomy; vomiting; nausea

Introduction nausea and vomiting (PONV), with the highestincidence occurring after strabismus surgery (1),

Although paediatric adenotonsillectomy is associatedantiemetics are not routinely used because of the

with the second highest incidence of postoperativerelatively high incidence of drug related adverseeffects in younger patients (2). The selective 5-HT3

receptor antagonist ondansetron has been shown toCorrespondence to: N.S. Morton, Department of Paediatric

be effective and well tolerated in adults and childrenAnaesthesia and Intensive Care, Royal Hospital for Sick Children,Yorkhill NHS Trust, Glasgow G3 8SJ, Scotland, UK. for the prevention and treatment of nausea and

37 1997 Arnette Blackwell SA

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38 N.S. MORTON ET AL .

vomiting after chemotherapy (3), radiotherapy (4) used as premedication, no propofol was used foranaesthetic maintenance and nitrous oxide was usedand surgery (5–11).

In a paediatric surgery study, results showed in all patients.The primary assessment of efficacy was based onthat ondansetron 0.05 mg·kg−1 i.v. should achieve

comparable results to that seen with a dose of 4 mg the proportion of children experiencing no emeticepisodes (defined as retching and/or vomiting)i.v. in healthy adults (12). Based on these results,

the authors recommended a dose of ondansetron during the 24 h period after recovery fromanaesthesia (defined as the patient’s first response to0.1 mg·kg−1 for children weighing up to 40 kg since

emesis in these patients is more common and of a spoken command). Patients who were given rescueantiemetic medication were regarded as treatmentgreater severity than observed in adults (1). There

have been four small paediatric tonsillectomy studies failures.The secondary assessments of efficacy were thepublished which have all used an ondansetron dose

of 0.15 mg·kg−1 (6–8,10). Ondansetron in this single number of emetic episodes, time to the first emeticepisode, the occurrence and severity of nausea,high dose was found to be as effective as or superior

to droperidol (6,7) and superior to metoclopramide patient requirement for nursing management ofPONV and medical or surgical problems attributable(6,10) and placebo (6–8,10) in preventing

posttonsillectomy emesis in children. The present to PONV. Emetic episodes were recordedcontinuously throughout the 24 h post-recoverylarge study aimed to establish the efficacy, safety and

resource implications of a slightly lower dose of period. Nausea was assessed at 1, 2, 4 and 24 hpostrecovery. The worst severity of nausea duringondansetron (0.1 mg·kg−1, maximum 4 mg) in

children undergoing adenotonsillectomy. each assessment period was recorded as either ‘None,mild, severe or unable to record’.

Safety was assessed by monitoring for adverseevents for the 24 h study period after recovery fromMethodsanaesthesia.

Resource implications were assessed by noting theLocal ethics committee approval was granted in 34European centres to study ASA grade 1 or 2 children number of children requiring nursing intervention

for PONV and its duration. The type of interventionaged 2–12 years scheduled for tonsillectomy with orwithout adenoidectomy under general anaesthesia. and resources needed, such as bed linen and vomit

bowls were recorded.One patient aged 1 year was recruited in error andreceived ondansetron. This patient was included in The proportion of patients expected to experience

no emesis after placebo was 45%. To detect a 15%the primary analysis. Written informed consent wasobtained from the parents of 427 children who were increase in this percentage due to ondansetron with

a power of 80% and a significance level of 5% requiredrandomly allocated to receive either a singleintravenous dose of ondansetron, as ondansetron 173 patients per treatment group. A total of 420

patients (210 per group) were planned to be recruitedhydrochloride dihydrate (0.1 mg·kg−1, maximum4 mg) or placebo (0.9% saline) which was to allow for unavailable patients.

All significance tests were two sided and wereadministered over at least 30 s immediately prior toor after induction of anaesthesia using a double-blind performed using SAS version 6.08 for Windows.

Mantel-Haenzel chi-squared tests were used tomethodology.A total of 212 children received ondansetron and separately compare the proportions of patients in

the ondansetron and placebo treatment groups with215 received placebo. 210/427 (49%) were male andadenotonsillectomy was performed in 303/427 (71%) complete control of postoperative nausea and emesis,

and also the proportion of patients rescued orwith 123/47 (29%) undergoing tonsillectomy aloneand one patient undergoing only adenoidectomy. withdrawn from the study. The Wilcoxon rank sum

test was used to compare the distributions of theThe use of licensed antiemetics and duration ofhospital stay, provided it was longer than 4 h after number of emetic episodes experienced during the

24 h post-recovery period, the time to the first emeticsurgery, was at the discretion of each centre but wasrecorded in detail. No trimeprazine or opioids were episode, the nausea severity, the duration of

1997 Arnette Blackwell SA, Paediatric Anaesthesia, 7, 37–45

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ONDANSETRON AND PONV AFTER TONSILLECTOMY 39

Table 1Summary of demographic data Placebo Ondansetron Total

Number of patients 215 212 427Sex Males 111 (52%) 99 (47%) 210 (49%)

Females 104 (48%) 113 (53%) 217 (51%)Age (yrs) Mean 6 6 6

Range 2–12 1–12 1–12Weight (kg) Males Mean 22.0 23.7 22.8

Range 10.5–50.0 12.0–63.5 10.5–63.5Females Mean 25.6 23.9 24.7

Range 12.9–62.0 11.0–73.3 11.0–73.3Ethnic origin Caucasian 205 (95%) 192 (91%) 397 (93%)

Noncaucasian 10 (5%) 20 (9%) 30 (7%)Pulse rate (beats/min) Mean 93 94 93

Range 58–135 52–131 52–135Systolic BP (mmHg) Mean 107 107 107

Range 80–160 80–160 80–160Diastolic BP (mmHg) Mean 64 64 64

Range 39–100 40–100 39–100No previous PONV history 201 (93%) 200 (94%) 401 (94%)Previous PONV history 14 (7%) 11 (5%) 25 (6%)PONV history not recorded 0 (0%) 1 (1%) 1 (<1%)Surgery type Adenotonsillectomy 152 (71%) 151 (71%) 303 (71%)

Tonsillectomy 63 (29%) 60 (28%) 123 (29%)Adenoidectomy 0 (0%) 1 (1%) 1 (<1%)

Duration of anaesthesia (min) Median 36 36 36Time to recovery (min) Median 15 15 15

anaesthesia, and the time to recovery in the premedicants, anaesthetic agents, analgesia andondansetron and placebo treatment groups. The rescue antiemetic drugs used in the different studyeffects of sex, age, weight, ethnic origin, type of centres was similar in both treatment groups. Insurgery, previous PONV history and opioid use on particular, a similar proportion of children in placebocontrol of PONV were investigated using logistic and ondansetron treated groups receivedregression analysis. The incidence rates of the most intraoperative opioids (88% vs 90%), postoperativecommonly occurring adverse events were compared opioids (41% vs 40%), volatile agents (93% vs 92%),between treatments using two-sided Fisher Exact muscle relaxants (62% vs 64%) and anticholinesterasetests. and anticholinergics (21% vs 24%) with comparable

proportions receiving the various types of each ofthese classes of drugs.

Compared with placebo treated children,Results significantly more ondansetron treated children had

no emetic episodes (Table 2; 127/212 (60%) vs 100/215A total of 427 children were studied with 212(47%); P=0.004) and experienced no postoperativerandomized to the ondansetron treatment group andnausea (Table 3; 135/211 (64%) vs 108/213 (51%);215 to the placebo treatment group. The groups wereP=0.004) in the first 24 h. For those who experiencedwell matched for sex, age, weight, ethnic origin,emesis, significantly fewer emetic episodes followedpreoperative pulse rate, preoperative blood pressure,ondansetron treatment (Table 2; P<0.001) and theprevious PONV history, type of surgery, durationtime to the first emetic episode was significantlyof anaesthesia and time to recovery (Table 1). The

proportion of patients receiving the various prolonged after ondansetron treatment (Table 3;

1997 Arnette Blackwell SA, Paediatric Anaesthesia, 7, 37–45

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40 N.S. MORTON ET AL .

Table 2Emesis recorded during the 24 hpostrecovery period

Placebo Ondansetron P value

Number of patients 215 212No emetic episodes 100 (47%) 127 (60%) 0.004Rescued/withdrawn due to treatment failure 21 (10%) 10 (5%) 0.042Number of emetic episodes 1 31 (14%) 28 (13%)

2 18 (8%) 21 (10%)3 10 (5%) 7 (3%)4 13 (6%) 9 (4%)5 6 (3%) 6 (3%)

>5 16 (7%) 4 (2%)Comparison of total number of emetic episodes — — <0.001

Table 3Time to the first emetic episodeduring the 24 h postrecoveryperiod

Placebo Ondansetron P value

Number of patients 215 212Time to first emetic episode/treatment failure 0–1 h 39 (18%) 15 (7%)

1–2 h 14 (7%) 6 (3%)2–4 h 19 (9%) 7 (3%)4–8 h 15 (7%) 23 (11%)8–16 h 19 (9%) 16 (8%)

16–24 h 9 (4%) 18 (8%)Comparison of overall time to firstemetic episode/treatment failure — — <0.001

Table 4Nausea recorded during the 24 hpostrecovery period

Placebo Ondansetron P value

Number of patients 215 212No nausea 108 (51%) 135 (64%) 0.004Nausea grade Mild 59/213 (28%) 47/211 (22%)

Severe 25/213 (12%) 19/211 (9%)Unable to record 2 1

Comparison of overall nausea grade — — 0.003

P<0.001). For those who experienced nausea, it was Analysis by gender revealed a significant treatmentdifference in favour of ondansetron for the proportionsignificantly less severe in ondansetron treated

children (Table 4; P=0.003). A significantly lower of girls who experienced no emesis (61% vs 43%,P=0.008), the proportion of girls with no nauseaproportion of ondansetron treated children had to

be rescued or withdrawn from the study (Table 2; (63% vs 48%, P=0.023), the reduction in the num-ber of emetic episodes (P=0.001), nausea grade5% vs 10%; P=0.042).

1997 Arnette Blackwell SA, Paediatric Anaesthesia, 7, 37–45

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ONDANSETRON AND PONV AFTER TONSILLECTOMY 41

Table 5Summary of most commonadverse events

Placebo Ondansetron P value

Number of patients 215 212Number of patients with any adverse event 26 (12%) 26 (12%)Headache 1 (<1%) 7 (3%) 0.076Haemorrhage 5 (2%) 3 (1%) 0.682Nausea and/or vomiting 4 (2%) 2 (<1%) 0.648Bradycardia 0 (0%) 4 (2%) 0.134

Table 6Other resources used to managepostoperative nausea and/oremesis

Placebo Ondansetron P value

Number of patients 215 212Patients requiring nursing management time∗ (%) 97 (45) 71 (34) 0.007Mean nursing management time∗ (min) 8.1 4.6 0.001Number of patients stay in hospital prolonged(total additional hours) 5 (104) 2 (72) —

∗ 0–24 h postrecovery, or up to discharge, if earlier.

(P=0.023) and the proportion of girls who were nausea was similar in both treatment groups (placebo7/14, 50%; ondansetron 6/11, 55%). However, in therescued or withdrawn (P=0.026). For males the

overall incidence of PONV was slightly less (no majority of patients who had no previous history ofPONV, the complete control of PONV withemesis: ondansetron 59%, placebo 50%; no nausea:

ondansetron 65%, placebo 54%) and of the ondansetron (no emesis: 124/200, 62%; no nausea:128/200, 64%) was superior to that with placebo (nocorresponding treatment effects noted for girls, only

the reduction in the number of emetic episodes emesis: 94/201, 47%; no nausea: 101/201, 51%).In the placebo treatment group, the use of propofol(P=0.046) and the nausea grade (P=0.049) were

significantly reduced by ondansetron in boys. for induction of anaesthesia did not affect thecomplete control of postoperative nausea (20/44,Overall, the complete control of PONV achieved with

ondansetron was similar for both girls and boys. 45%) or emesis (19/44, 43%) compared to whenpropofol induction was not used (no nausea: 88/171,Patient subgroup analysis showed that the

incidence of emesis was slightly higher and the 52%; no emesis: 81/171, 47%). A similar proportion ofondansetron treated patients experienced no nauseaincidence of nausea was slightly lower in those

children aged <5 years. This may be due to the with (21/35, 60%) or without (114/177, 65%) propofolinduction, whereas more propofol induced patientsdifficulty in assessing nausea in young children. The

type of surgery (adenotonsillectomy vs tonsillectomy) experienced no emesis (26/35, 75% vs 101/177, 57%).The overall incidence of adverse events was 12%did not affect the control of nausea or emesis. Opioids

increased the incidence of both nausea and emesis with ondansetron and placebo (Table 5). Headachewas the most common drug related adverse eventwhether given intraoperatively or in the

postoperative period. Of the 25 patients (6%) who (3%) and is a well recognized effect of ondansetron.Compared with placebo treated children thegave a previous history of PONV, the proportion of

patients recording no emesis was higher in the incidence was not significant.The frequency and duration of nursingplacebo treatment group (6/14, 43% vs 2/11, 18%)

whereas the proportion of patients recording no interventions for management of PONV were

1997 Arnette Blackwell SA, Paediatric Anaesthesia, 7, 37–45

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42 N.S. MORTON ET AL .

Table 7Frequency (%) patients requiringresources to managepostoperative nausea and/oremesis 0–24 h postrecovery, orup to discharge if earlier

Total Pairs Bedresource Vomit of Paper linen Other

items bowls Gowns gloves towels changes items

Total number of patientsrequiring items 174 155 36 44 144 63 44Number of ondansetronpatients requiringitems (%) 75 (43) 62 (40) 12 (33) 14 (32) 63 (44) 22 (35) 16 (36)Number of placebopatients requiringitems (%) 99 (57) 93 (60) 24 (67) 30 (68) 81 (56) 41 (65) 28 (64)P value 0.014 0.001 0.034 0.009 0.054 0.008 0.059

significantly reduced by ondansetron treatment Anaesthetic factors(Table 6). Fewer resources were required to manage

Tracheal intubation, some induction agents, volatilepostoperative nausea and/or emesis in ondansetron

anaesthetic agents, nitrous oxide and opioids alltreated children (Table 7).

exacerbate PONV (14) and are relevant in paediatricadenotonsillectomy. In this study all children wereintubated and all received nitrous oxide and a volatile

Discussion agent, either halothane, enflurane or isoflurane.Propofol, which is known to have antiemeticSurgical, anaesthetic and patient factors contributeproperties (16), was used in 79/427 (19%) childrento PONV after paediatric adenotonsillectomy (13,14).for induction but not maintenance of anaesthesia inStimulation of afferent vagal fibers in the gut andthis study. Subgroup analysis showed that propofolliver, afferents from the trigeminal nerve distributioninduction did not influence the overall placeboand the vestibulator labyrinthine and brainstemincidence or severity of PONV significantly in thisvomiting systems all involve 5HT3 receptors. It isstudy. Ondansetron produced a greater reduction inlogical to use a selective 5HT3 receptor antagonist topostoperative emesis in the subgroup who receivedameliorate the effects of swallowed blood, surgicalpropofol induction compared with placebo, whereasstimulation, anaesthetic drugs, opioids and patienta similar reduction in postoperative nausea wasmovement associated with adenotonsillectomy (15).observed in both the propofol and nonpropofolinduction subgroups. Nitrous oxide, volatile agentsand opioids were used in this trial and the latter

Surgical factors produced a higher incidence of PONV in both placeboand ondansetron treated children.Stimulation of the trigeminal nerve during surgery

Antiemetic premedicants were not used in thisand swallowed blood irritating chemoreceptors in thestudy and other antiemetics were only used for rescueoesophagus, stomach and small bowel are importanttherapy.surgical factors. Use of electrocautery during surgery

is said to be associated with more stimulation andpostoperative pain than a dissection/tie technique. Patient factorsStandardization of surgical technique, operator andblood loss was not attempted in this study but there The incidence of PONV varies with age, with a lower

occurrence in infants and a peak incidence at age 6may be a place for a single operator, single techniquestudy to minimize the surgical variables. to 16 years (13,14,17). Children undergoing ENT,

1997 Arnette Blackwell SA, Paediatric Anaesthesia, 7, 37–45

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ONDANSETRON AND PONV AFTER TONSILLECTOMY 43

ophthalmic and upper abdominal surgery are at Pharmacoeconomicsparticular risk of PONV (14). In this ENT study

The analysis of resource savings, need for nursingPONV was common in the placebo group but was

time, and the use of recent medication may allaysignificantly reduced by a single dose of ondansetron.

fears concerning the capital costs of widespreadThe gender difference in the incidence of PONV in

prophylactic use of a new antiemetic agent. Whenadults is not evident in children (1,14) and was not

extrapolated to very large patient numbers, thesignificant in this study.

savings in terms of reduced resource consumptionThose who have a past history of PONV or a

may offset this capital cost. This study demonstrateshistory of motion sickness are said to be at particular

significantly reduced resource utilization in additionrisk of PONV (14). Due to the small number of

to the beneficial clinical effect of a 13% reduction inpatients with a previous history of PONV (25/427,

PONV.6%) it was not possible to draw any conclusions asto the relative effectiveness of ondansetron in thisgroup compared to those without a previous historyof PONV. A detailed study of such a patient group Towards an optimum anaesthetic technique forwould be of value. Ondansetron, however, has been adenotonsillectomyshown to be of benefit in adult patients with a

Avoidance of as many risk factors for PONV asprevious history of PONV (9,11).possible points to an anaesthetic technique wheretraditional volatile agents, nitrous oxide and opioidsare omitted and a prophylactic antiemetic with

Efficacy and adverse effects of antiemetics in minimal adverse effects is given. Ondansetron fulfilschildren undergoing adenotonsillectomy the latter role and propofol infusion anaesthesia (23),

use of NSAIDS in place of opioids (24,25), andOther antiemetics which have been shown to beperhaps use of a laryngeal mask airway (if it iseffective in children, include metoclopramide,validated for safety in children) are possible futuredroperidol, prochlorperazine and trimeprazine.developments in anaesthetic technique.These agents produce a high incidence of adverse

Improvements are clearly required when com-effects in children, especially sedation, excitatorymonly used current techniques resulted in significantphenomena and extrapyramidal effects (2). Use ofnausea and emesis in approximately half the childrenlower doses does reduce the adverse effects but alsoin the placebo group in the present study. After a singleresults in a loss of efficacy (10,18). However, lowdose of ondansetron 0.1 mg·kg−1, PONV occurreddoses of droperidol (5–20 lg·kg−1) are commonlyin only about one third of children undergoingused and have been extensively used in childrenadenotonsillectomy and the severity of nausea wasundergoing strabismus surgery, general day casereduced in a well tolerated and cost effective manner.surgery and ENT surgery (18–21).

Previously published comparative paediatricstudies have revealed significantly better control ofPONV with ondansetron 0.15 mg·kg−1 compared Acknowledgementswith low (20–25 lg·kg−1) or high (75 lg·kg−1) dosedroperidol or metoclopramide (6,8,10). The present We thank the following investigators who assisted

greatly with the recruitment of patients into this study:study shows that ondansetron at a dose of 0.1 mg·kg−1

(maximum 4 mg) is efficacious and has a very Dr B.N. Andersen, Dr H.A. Jørgensen, Viborg Sygehus,Viborg, Denmark; Dr G. Angergard, Vastervikfavourable adverse effect profile. Indeed the

incidence of adverse effects (12%) with ondansetron sjukhus, Vastervik, Sweden; Dr C. Best, Dr R. Lawson,Royal Hospital for Sick Children, Glasgow, UK; Drwas similar to placebo. Headache was the most

common drug related adverse event and is a P.D. Booker, Dr C. Evans, Dr H. May, Alder HeyChildren’s NHS Trust, Liverpool, UK; Dr J.M. Cos,recognised effect of ondansetron. Other adverse

events reported in both groups were typical of Clinique St Laurent du Var, St Laurent du Var, France;Dr V.A. Derijcke, Dr N. Muller, Dr B. Vangehuchten,children undergoing adenotonsillectomy.

1997 Arnette Blackwell SA, Paediatric Anaesthesia, 7, 37–45

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44 N.S. MORTON ET AL .

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surgery in pediatric outpatients. Anesthesiology 1991; 75:204–209. Accepted 16 April 1996

1997 Arnette Blackwell SA, Paediatric Anaesthesia, 7, 37–45