Accepted: 23 April 2017
DOI: 10.1111/pan.13179
RESEARCH REPORT
Effects of intraoperative liberal fluid therapy on
postoperative nausea and vomiting in children—A
randomized controlled trial
Vighnesh Ashok1 | Indu Bala1 | Neerja Bharti1
1
Department of Anesthesia and Intensive
Care, Post Graduate Institute of Medical
Education and Research, Chandigarh, India
2
Department of Pediatric Surgery, Post
Graduate Institute of Medical Education
and Research, Chandigarh, India
Correspondence
Neerja Bharti, Department of Anesthesia
and Intensive Care, PGIMER, Chandigarh,
India.
Email: bhartineerja@yahoo.com
Funding information
This work was supported by the Department
of Anesthesiology and Intensive Care, Post
Graduate Institute of Medical Education and
Research, Chandigarh, India.
Section Editor: Francis Veyckemans
Pediatric Anesthesia. 2017;1–6.
| Divya Jain1 | Ram Samujh2
Summary
Background: Postoperative nausea and vomiting (PONV) is one of the most dis-
tressing complications following surgery. Supplemental perioperative fluid therapy
might be an effective strategy to reduce PONV in children.
Objectives: The study was conducted to evaluate the effects of intraoperative lib-
eral fluid therapy with crystalloids on PONV in children.
Methods: In this randomized trial, a total of 150 children of 3-7 years undergoing
lower abdominal and penile surgery under general anesthesia were randomly assigned
into two groups. “Restricted group” received 10 mL kg 1
h 1
and “Liberal group”
1 1
received 30 mL kg h infusion of Ringer’s lactate solution intraoperatively. All
patients received a caudal block and intravenous paracetamol for analgesia. No opioids
and muscle relaxants were used. All episodes of nausea-vomiting and the requirement
of rescue antiemetic were assessed during 24 hours postoperatively.
Results: The incidence of PONV was significantly less in the liberal group patients
as compared to the restricted group; 33 (45.8%) patients in the restricted group had
vomiting as compared to 20 (27.4%) patients in the liberal group (RR 0.59, 95% CI:
0.38-0.93, P=.021). The adjusted odds ratio of PONV for the liberal group vs
restricted group was 2.24 (95% CI: 1.12-4.48, P=.022). The incidence of fluid intake
during the first 6 postoperative hours was significantly higher in the restricted group
patients; 60 (83%) children in the restricted group complained of thirst as compared
to 12 (17%) children in the liberal group (RR 0.19, 95% CI: 0.18-0.33, P=.0001). The
parents of the liberal group were more satisfied as compared to the restricted group
(mean difference 0.9, 95% CI: 1.8, 0.1, P=.04). None of the children had any
complication attributed to the liberal fluid therapy.
Conclusion: Liberal intraoperative fluid therapy was found to be effective in reduc-
ing PONV in children undergoing lower abdominal surgery.
KEYWORDS
anesthesia, general, children, crystalloid solutions, fluid therapy, postoperative nausea and
vomiting, thirst
wileyonlinelibrary.com/journal/pan © 2017 John Wiley & Sons Ltd | 1
2 |
1 | INTRODUCTION
Postoperative nausea and vomiting (PONV) is one of the most com-
mon complaints following surgery, and pediatric patients are not
spared from it.1 In addition to being a very unpleasant and distress-
ing experience for the children and their parents, PONV may lead to
prolonged stay in the Post Anesthesia Care Unit (PACU), delayed
discharge from the hospital, and unplanned hospital readmission.
Moreover, emetic episodes can also cause serious medical complica-
tions like aspiration of gastric contents, suture dehiscence, dehydra-
2 tive nausea and vomiting in children undergoing lower
tion, and electrolyte disturbances.
Pharmacological prophylaxis against PONV may not be appropri-
ate for all patients because of the cost involved, limited efficacy, and
the risk of adverse effects of several antiemetics.3 Perioperative lib-
eral fluid therapy might be an inexpensive and safer alternative to
prevent PONV.4-8 However, very few studies have been conducted
in the pediatric population and with varying results.9,10
Lower abdominal surgeries and penile surgeries are the most
commonly performed surgical procedures in pediatric patients, with
an overall PONV incidence of about 40%.11 The present study was
planned to evaluate the antiemetic efficacy of intraoperative liberal
fluid therapy with crystalloids in children undergoing elective lower
abdominal and penile surgeries. Furthermore, the secondary effects
of liberal fluid therapy on postoperative thirst and pain were also
studied.
2 | METHODS
In this randomized double-blind study, 150 ASA physical status I and
II children, aged 3-7 years, scheduled to undergo elective lower
abdominal and penile surgeries of <60 minutes duration, were
included. The patients were recruited after institutional ethics com-
mittee approval (NK/1145/MD/13382) and written informed con-
sent from the parents or legal guardians. The exclusion criteria were
antiemetic therapy within 24 hours before surgery, cardiovascular
and renal disease, past history of PONV in patient, sibling and/or
2 1
parent, history of motion sickness, obesity (BMI>30 kg m ), devel-
opmental delay and/or mental retardation, children whose parents
could not be contacted by telephone, and any contraindications to
caudal block.
Children were randomly allocated into the “restricted group” and
the “liberal group” by computer-generated randomization. They were
fasted 6 hours for solid food and 2 hours for sugar containing clear
1
fluids and were premedicated with oral midazolam 0.5 mg kg
30 minutes prior to induction of anesthesia. Anesthesia was induced
with sevoflurane 5%-8% in 100% oxygen. Caudal block was adminis-
1
tered with 0.75 mL kg of 0.25% plain bupivacaine after which a
laryngeal mask airway of appropriate size was inserted. Surgery com-
menced 10 minutes after the administration of caudal block. General
anesthesia was maintained with sevoflurane 0.5%-2% with 60% N2O
in O2 to maintain a MAC of 1.2 and endtidal carbon-di-oxide
between 35 and 40 mm Hg. Sevoflurane concentration was adjusted
ASHOK ET AL.
What is already known
• Intraoperative liberal fluid therapy may reduce the inci-
dence of postoperative nausea and vomiting; however,
very few studies have been conducted in the pediatric
population.
What this article adds
• Liberal fluid therapy is effective in reducing postopera-
abdominal surgery.
• Incidence of thirst was also less in children receiving
1 1
30 mL kg h fluid intraoperatively.
to achieve hemodynamic changes within 20% of the baseline values.
The patients were monitored for continuous ECG, heart rate, oxygen
saturation, and noninvasive blood pressure recorded at 10-minute
intervals.
Patients received, intraoperatively, infusion of either
1 1 1 1
10 mL kg h (restricted group) or 30 mL kg h (liberal group)
of dextrose-free Ringer’s lactate solution, according to the group
allocation. The subjects, parents or guardians, surgeons, PACU
nurses, and the investigator performing the postoperative assess-
ment were blinded to the group allocation. The intravenous fluid
was administered with an infusion pump by an anesthesiologist not
involved in data collection in the postoperative period. Analgesia
1
was supplemented with paracetamol 15 mg kg i.v. at the time of
skin closure. No intraoperative opioids, antiemetics, or neuromuscu-
lar blocking agents were given. At the end of surgery, sevoflurane
and nitrous oxide were stopped, and the laryngeal mask airway was
removed when the child was awake and breathing spontaneously.
Postoperatively, the children were observed in PACU for moni-
toring of vital signs and PONV. The data were collected by a single
investigator, who was blinded to the group allocation. All episodes
of nausea, retching, and emesis were recorded. Ondansetron
0.1 mg kg i.v. was given at the first episode of retching and/or
vomiting. If retching and/or vomiting persisted for more than
30 minutes after administration of ondansetron, the second rescue
1
antiemetic, promethazine 0.5 mg kg i.v was given. Complete
response was defined as no nausea or vomiting with no administra-
tion of any antiemetic medication during the 24 hours postopera-
tively and was the primary efficacy end point. No additional
, intravenous fluids were given in the PACU. Children were allowed to
drink liquids when they were fully awake and demanded so. The
time when the child asked for oral fluids was also recorded. Postop-
erative pain was assessed using the Face, Legs, Activity, Cry, Con-
solability (FLACC) pain scale (0-10 score range). If FLACC score was
1
4 or greater, paracetamol 15 mg kg was given intravenously.
The children were discharged from the PACU, either home or to
the ward, according to standard clinical practice that is patient
awake, no apparent bleeding, hemodynamically stable, clear airway,
ASHOK ET AL.
pain well-controlled, and no nausea or vomiting. Parents were
1
advised to give oral paracetamol 15 mg kg if the child complained
of pain and/or had fever (oral temperature >37.5°C) and oral
1
promethazine 0.5 mg kg if the child had severe nausea/retching/
vomiting, following discharge from PACU. The same protocol was
followed in the ward as well. The parents were contacted by tele-
phone after 24 hours and details regarding nausea, vomiting, fever,
requirement of rescue antiemetics, and analgesics were collected
and the overall parent satisfaction score (0-10, 0—completely unsat-
isfied, 10—completely satisfied) was enquired about. The same data
were collected from admitted patients as well.
The incidence of PONV in children undergoing lower abdominal
and penile surgeries has been found to be 40% or higher. Taking an
incidence of 40% and presuming that after intraoperative liberal fluid
therapy, there would be a 30% reduction in the incidence of PONV,
we calculated a sample size of 67 patients in each group with a=.05
and b=.80. Allowing for possible drop-outs, a total of 150 patients
were enrolled in the study. The statistical analysis was carried out
using Statistical Package for Social Sciences (version 21; SPSS Inc,
Chicago, IL, USA). All quantitative variables were estimated using
measures of central tendency and measures of dispersion. Normality
of data was checked by measures of skewness and Kolmogorov-
Smirnov test. The normally distributed data was compared using Stu-
dent’s t test. For skewed data, Mann-Whitney U test was applied. A
repeated measure ANOVA was used to compare the difference
between time-related variables. Proportions were compared using
chi square or Fischer’s exact test. Relative risk and the corresponding
95% confidence intervals were reported.
Postoperative vomiting was analyzed using logistic regression.
Variables identified as potential confounding factors in previous
studies and those with a P-value of <.25 in the univariable analysis
were included in the multivariable logistic regression model. Using a
backward elimination approach, the likelihood ratio test comparing
the model including the variable with the nested model excluding it,
was used to assess whether the variable contributed significantly to
the model. Hosmer-Lemeshow goodness-of-fit test was used to
12
assess calibration of the model. All statistical tests were two-sided
and were performed at a significance level of a=.05.
3 | RESULTS
A total of 145 children completed the study. Five patients were lost
to follow-up after they had been discharged from PACU and were
excluded from the analysis (Figure 1). Both the groups were well
matched with respect to demographic data, type of surgery, and the
duration of anesthesia (Table 1). The perioperative heart rate, oxy-
gen saturation, and mean arterial pressure were comparable among
the two groups.
The incidence of PONV was significantly less in liberal group
patients as compared to the restricted group. During 24 hours, 33
(45.8%) patients in restricted group had at least one episode of vom-
iting compared to 20 (27.4%) patients in the liberal group (relative
| 3
T A B L E 1 Demographic data, type, and duration of surgery
Restricted group Liberal group
(n=72) (n=73)
Age (years) 5.3 (1.5) 5.1 (1.6)
Weight (kg) 17.3 (4.2) 16.39 (3.5)
Male:Femalea 65:7 69:4
Type of surgery,a 46/26 44/29
Lower abdominal/penile
Duration of surgery (min) 44.93 (11.4) 46.10 (10.7)
Values are expressed in mean (SD).
a
Data presented as number of patients.
risk 0.59, 95% CI: 0.37-0.93, P=.021). No PONV was observed in 39
(54.2%) children in restricted group and 53 (72.6%) children in liberal
group. Though, the time to first rescue antiemetic was longer in lib-
eral group, it was not statistically significant (P=.337) (Table 2).
The incidence of fluid intake during first 6 postoperative hours
was significantly higher in restricted group patients. Overall, 60
(83%) children in restricted group complained of thirst as compared
to 12 (17%) children in liberal group (RR 0.19, 95%CI: 0.18-0.33,
P=.0001) which was also reflected by the earlier demand of oral flu-
ids in restricted group (Table 2). Logistic regression analysis showed
that none of the independent variables considered, other than liberal
intraoperative fluids, had any significant effect over the incidence of
PONV (Table 3). When age, weight, gender, duration of anesthesia,
pain, thirst, and treatment group were regressed on PONV, the only
significant predictor of PONV was the treatment group. The
adjusted odds ratio of PONV for the liberal group vs restricted group
was 2.24 (95% CI: 1.12-4.48, P=.022).
The postoperative pain scores and the requirement of rescue
analgesics were comparable between the groups. During 0-24 hours,
24 (33.3%) children in restricted group and 21 (28.8%) children in
liberal group required rescue analgesia (P=.552). Overall parent satis-
faction score was significantly higher in liberal group as compared to
the restricted group (P=.04). None of our patients had fever or
developed any complication attributed to the liberal fluid therapy.
4 | DISCUSSION
The average incidence of PONV is reported to be 40% or greater in
children aged 3 years and older.13 In the present study, 46% children
in restricted group experienced PONV during 24 hours, which is
consistent with the previously reported incidence. We observed a
significant decrease in the incidence of PONV in children who
received liberal fluid therapy (27%) with complete response rate of
73% and a relative risk reduction of 41%. This represents a relative
risk of PONV of 0.59 with liberal fluid therapy (95% confidence
interval 0.38, 0.93).
Similarly, in the previous study, Goodarzi et al.9 found 22% inci-
1 1
dence of PONV in children receiving 30 mL kg h fluid therapy
1 1
as compared to 54% in 10 mL kg h group, with a relative risk
4 | ASHOK ET AL.

Assessed for eligibility

(n=150)

Enrollment Excluded (n=0)

Is it Randomized?
Yes – 2 groups

Allocated to intervention Allocated to intervention

(n=75) (n=75)
Received allocated Received allocated
intervention intervention
(n=75) (n=75)

Allocation

Lost to follow-up (n=3) Lost to follow-up (n=2)

Discontinued intervention Follow-Up Discontinued intervention

(n=0) (n=0)

Analyzed (n=72) Analyzed (n=73)

Analysis
Excluded from analysis (n=3) Excluded from analysis (n=2)

FIGURE 1 Flowchart

T A B L E 2 Postoperative data
Variables Restricted group (n=72) Liberal group (n=73) Relative risk (95% CI) P-value
Incidence of PONV, n (%) 33 (46%) 20 (27%) 0.59 (0.37,0.93) .021
Incidence of increased thirst, n (%) 60 (83%) 12 (17%) 0.19 (0.18, 0.33) <.0001
Requirement of rescue analgesia, n (%) 24 (34%) 21 (29%) 0.86 (0.53, 1.40) .55
Time to first rescue antiemetic, mina 62.3 (58.5) 81 (65.2) 18.7 ( 38.35, 0.95) .337
Time of demand of oral fluids, mina 68.5 (31.5) 141.6 (46.5) 83.2 ( 96.11, 70.29) <.0001
Time to first rescue analgesia, mina 85.7 (30.8) 100 (46.7) 14.3 ( 27.15, 1.45) .36
a
Overall parent satisfaction score 6.5 (2.7) 7.4 (2.3) 0.9 ( 1.8, 0.1) .041

Values are presented in number (percentage) of patients, relative risk and 95% confidence interval.
a
Data presented as mean (SD), mean difference, and 95% confidence interval.

reduction of 59%, in children undergoing strabismus repair. How-
ever, Elgueta et al.10 observed only 24% relative risk reduction in
children receiving liberal fluids administration during tonsillectomy.
The higher incidence of PONV in this study in both the groups (82%
and 62% in restricted and liberal fluid groups respectively) could be
due to the perioperative opioids administration.10 Perioperative use
of opioids has been implicated as an important risk factor in the
development of PONV due to sensitization of chemoreceptor trigger
zone and vestibular apparatus. We did not use opioids in our study.
In the present study, significantly greater number of patients
required rescue antiemetics during 0-6 hours in restricted group
(38.9%) as compared to the liberal group (20.5%), although all our
ASHOK ET AL.
T A B L E 3 Univariable analysis using logistic regression. Composite
outcome—postoperative nausea and vomiting
Independent variables P-value Odds ratio (95% CI)
Age (years) .598 1.095 (0.782, 1.531)
Female a
.106 0.322 (0.081, 1.273)
Weight (kg) .500 1.048 (0.914, 1.202)
Duration of surgery (1 min) .440 1.015 (0.978, 1.052)
Pain .167 0.556 (0.241, 1.279)
Thirst (yes/no) .703 0.830 (0.317, 2.170)
Liberal groupa .022 0.446 (0.223, 0.891)
a
Reference gender is male and reference group is restricted group.
patients responded to ondansetron and hence did not require the
second rescue antiemetic. The exact mechanism behind the antie-
metic effect of liberal fluid therapy is still unclear. The hypothesis is
that supplemental perioperative fluid therapy helps to correct any
existing fluid deficit caused by mandatory preoperative fasting. This
maintains circulating intravascular volume, thereby preventing
splanchnic vasoconstriction and mesenteric ischemia leading to sub-
sequent inhibition of serotonin production—a potent mediator of
nausea and vomiting.14 Another mechanism mediated by antidiuretic
hormone (ADH) has also been proposed. Anesthetic agents cause
vasodilatation inducing a state of relative hypovolemia. The reduced
negative feedback of the right atrial stretch receptors results in an
increased release of ADH which in turn leads to increase in the inci-
dence of PONV.15
The results of perioperative liberal fluid therapy on PONV in
adults are conflicting, reporting either improvement or no effect on
reduction of PONV.4-8 With our study demonstrating an absolute
risk reduction of PONV of 0.18 and a number needed to treat (NNT)
of 5.4, it appears that liberal fluid therapy might be more effective in
children as compared to adults. This is probably because pediatric
patients have higher baseline PONV rates and greater chance of pre-
operative hypovolemia due to larger body surface to weight ratio
and faster metabolic rates.
The patient characteristics, type of surgery, and anesthesia-
16
related factors may also affect the incidence of PONV. In the pre-
sent study, the age of the children, surgical duration (>30 minutes),
and use of inhalational anesthetics were the main risk factors for
PONV, although they were comparable among groups. The children
with high risk of PONV (>50%) including children with a past history
of PONV/motion sickness and family history of motion sickness
were excluded from the study. An opioid-free anesthesia technique
using caudal block and paracetamol was used. Therefore, prophylac-
tic antiemetic was not given. Instead, any postoperative nausea and
vomiting was treated effectively in the PACU before discharge. The
poor cost-effectiveness of routine antiemetic prophylaxis (based on
NNT) and the evidence that there is no significant difference in clini-
cal outcomes and patient satisfaction whether PONV was treated or
prevented17 have been other reasons for us to omit routine prophy-
lactic antiemetic therapy in our patients. Postoperative pain is an
important risk factor for the development of nausea and vomiting.
| 5
The FLACC pain scores and requirement of rescue analgesic were
comparable between the groups. After adjusting for possible con-
founding variables for PONV like, age, weight, gender, duration of
surgery, pain, and thirst, this represented an odds ratio of 2.24 (95%
CI: 1.22, 4.48) in the restricted fluid group.
Additionally, the children receiving liberal fluid therapy had less
incidence of thirst postoperatively. Goodarzi et al.9 also reported sig-
nificant decrease in thirst after liberal intraoperative fluid administra-
tion. In the present study, mandatory postoperative fasting for a
fixed duration was not enforced, nor was compulsory oral intake
used as a requirement for discharge from PACU. Patients were
allowed to take oral fluids on demand. While earlier studies advo-
cated against early oral intake following surgery, due to the
increased risk of nausea and vomiting,18,19 later studies have shown
that mandatory postoperative fasting does not reduce the incidence
of PONV.20 It has further been shown that the children who
received oral fluids on demand were less bothered by pain and
happier than those who were expected to fast postoperatively.21
Excessive fluid administration is however not without potential
side effects. Transient reduction in functional residual capacity and
diffusion capacity in healthy volunteers given large fluid volumes
has been reported.22 However, our study was done in children
undergoing short-duration surgery (<60 minutes), which makes the
chances of fluid overload almost impossible even in the children of
liberal fluid group. None of our patients who received liberal intra-
operative fluid showed any evidence of respiratory distress or
hypoxia. The volume of intraoperative fluid administration as
1 1 1 1
10 mL kg h and 30 mL kg h was chosen on the basis of
9,10
earlier such studies. We used Ringer’s lactate solution during
intraoperative period. Ringer’s lactate resuscitation in large volumes
may be associated with a fall in serum osmolarity. However, this
change has been found to be clinically insignificant and at the most
transient, returning to normal within 2-3 hours. In contrast, large
volume resuscitation with normal saline (NS) has been shown to
cause hyperchloremic metabolic acidosis. Ringer’s lactate has been
found to be safer than NS as a resuscitation fluid choice in
adults.23
The main limitation of this study is that our results cannot be
generalized for more invasive and long-lasting surgeries. Secondly,
some of our patients were admitted overnight due to the nature of
the surgical procedure. However, the number of patients admitted in
the ward after surgery was 26 (37%) in the restricted group and 29
(40%) in liberal group, with no significant difference between the
groups and hence this is unlikely to have affected the PONV out-
come in our study.
1 1
In conclusion, the administration of 30 mL kg h intravenous
fluid intraoperatively significantly reduces the incidence of PONV in
children undergoing lower abdominal and penile surgeries. The chil-
dren who received liberal fluids also had less thirst postoperatively.
The administration of liberal crystalloids was associated with greater
parental satisfaction with the management of PONV symptoms. Fur-
ther studies are required to access the effect of super hydration
therapy in different surgical procedures.
6 |
ETHICS APPROVAL
Ethics approval for this randomized double-blind parallel trial was
obtained from “Institute Ethics Committee” of the institute (ref. no.
MS/23142). The trial has been registered at “Clinical Trial Registry
of India” (CTRI), reference number REF/2015/06/009178.
CONFLICT OF INTERESTS
The authors report no conflict of interest.
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How to cite this article: Ashok V, Bala I, Bharti N, Jain D,
Samujh R. Effects of intraoperative liberal fluid therapy on
postoperative nausea and vomiting in children—A randomized
controlled trial. Pediatr Anesth. 2017;00:1-6. https://doi.org/
10.1111/pan.13179