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Original Article
©Copyright 2023 by the Turkish Anesthesiology and Reanimation Association / Turkish Journal of Anaesthesiology & Reanimation is published by Galenos Publishing House.
Licensed under a Creative Commons Attribution (CC BY) 4.0 International License.
420
Turk J Anaesthesiol Reanim 2023;51(5):420-426
Received: February 21, 2023 Accepted: July 04, 2023 Corresponding author: Mohamed Abdelgawad Abdelhalim Aboelsuod, e-mail: Abosoad.mohamed2017@gmail.com
Main Points
• The effect of ketamine on intraoperative blood pressure during cesarean delivery after spinal anaesthesia.
• Neonatal outcome after ketamine use in patients undergoing cesarean delivery after spinal anaesthesia.
• The effect of ketamine on shivering, sedation, and postoperative analgesia.
Mohamed Abdelgawad Abdelhalim Aboelsuod1 , Ahmed Mossad Ahmed Elnaggar1 , Tarek Abu Alkasem Abu
Alwafa1 , Mostafa Mohamed Hussien Ahmed1 , Ahmed Salah Ahmed Elbeltagy2 , Mohamed Ibrahim Abdelkader
Elbarbary2
1Department of Anaesthesia, Intensive Care and Pain Management, Faculty of Medicine Al-Azhar University, Cairo, Egypt
2Department of Obstetric and Gynecology, Faculty of Medicine Al-Azhar University, Cairo, Egypt
Cite this article as: Aboelsuod MAA, Elnaggar AMA, Alwafa TAAA, Ahmed MMH, Elbeltagy ASA, Elbarbary MIA. Effect of Intravenous Ketamine Infusion on Hemodynamics of
Patients Undergoing Cesarean Delivery after Spinal Anaesthesia: A Randomized, Double-Blind, Controlled Trial. Turk J Anaesthesiol Reanim. 2023;51(5):420-426.
Abstract
Objective: Hypotension is the most frequent side effect of intrathecal anaesthesia, with an incidence of more than 80%. Following neuraxial
anaesthesia, perioperative shivering is a serious complication affecting 40-60% of patients undergoing surgery. This study aimed to determine
the effectiveness of low-dose ketamine on blood pressure in patients undergoing cesarean delivery after spinal anaesthesia.
Methods: We included 126 female patients undergoing cesarean deliveries, American Society of Anesthesiologists (ASA)-(II and III), and
aged 21-40 selected from the outpatient clinics of the anaesthesia department. Patients were randomized to two groups; Group K (63
patients), who received 0.3 mg kg-1 of ketamine IV diluted to 10 mL, followed by an infusion of 0.1 mg kg-1 h-1. Group C (Controlled) (63
patients) received 10 mL of normal saline, followed by an infusion of 0.1 mL kg-1 h-1, which started before spinal anaesthesia.
Results: Compared with the saline group, the average heart rate, blood pressure, and level of sedation were significantly higher in the
ketamine group (P < 0.05). The ketamine group reported a significantly lower incidence of shivering (P < 0.01). The ketamine groups
exhibited significantly less mild or severe hypotension (P < 0.05). There was no significant difference between the two groups in terms of
nystagmus, diplopia, hallucinations, or neonatal outcomes (P > 0.05).
Conclusion: Ketamine decreases the incidence of hypotension and shivering in patients undergoing spinal anaesthesia during cesarean
delivery. In addition, it resulted in improved sedation for the mother and prolonged postoperative analgesia without neonatal illness.
Keywords: Hypotension, obstetric anaesthesia, pain, perioperative care, regional anaesthesia
Introduction
Hypotension is the most prevalent side effect of intrathecal anaesthesia, with an incidence of more than 80%.
The negative effects of hypotension during spinal anaesthesia for cesarean delivery include reduced uteroplacental
blood flow, impaired fetal oxygenation with asphyxia stress, and fetal acidosis, as well as maternal symptoms of low
cardiac output, such as nausea, vomiting, dizziness, and decreased consciousness. These adverse effects can harm
Effect of Intravenous Ketamine Infusion
on Hemodynamics of Patients Undergoing
Cesarean Delivery after Spinal Anaesthesia: A
Randomized, Double-Blind, Controlled Trial
Obstetric Anaesthesia
DOI: 10.4274/TJAR.2023.231231
Turk J Anaesthesiol Reanim 2023;51(5):420-426Aboelsuod et al. Ketamine Infusion on Hemodynamics for Patients Undergoing Cesarean Delivery
421
Abstract
Objective: Hypotension is the most frequent side effect of intrathecal anaesthesia, with an incidence of more than 80%. Following neuraxial
anaesthesia, perioperative shivering is a serious complication affecting 40-60% of patients undergoing surgery. This study aimed to determine
the effectiveness of low-dose ketamine on blood pressure in patients undergoing cesarean delivery after spinal anaesthesia.
Methods: We included 126 female patients undergoing cesarean deliveries, American Society of Anesthesiologists (ASA)-(II and III), and
aged 21-40 selected from the outpatient clinics of the anaesthesia department. Patients were randomized to two groups; Group K (63
patients), who received 0.3 mg kg-1 of ketamine IV diluted to 10 mL, followed by an infusion of 0.1 mg kg-1 h-1. Group C (Controlled) (63
patients) received 10 mL of normal saline, followed by an infusion of 0.1 mL kg-1 h-1, which started before spinal anaesthesia.
Results: Compared with the saline group, the average heart rate, blood pressure, and level of sedation were significantly higher in the
ketamine group (P < 0.05). The ketamine group reported a significantly lower incidence of shivering (P < 0.01). The ketamine groups
exhibited significantly less mild or severe hypotension (P < 0.05). There was no significant difference between the two groups in terms of
nystagmus, diplopia, hallucinations, or neonatal outcomes (P > 0.05).
Conclusion: Ketamine decreases the incidence of hypotension and shivering in patients undergoing spinal anaesthesia during cesarean
delivery. In addition, it resulted in improved sedation for the mother and prolonged postoperative analgesia without neonatal illness.
Keywords: Hypotension, obstetric anaesthesia, pain, perioperative care, regional anaesthesia
both the mother and newborn. Methods for preventing
and managing hypotension in obstetric anaesthesia have
garnered significant interest in the literature. However, there
is controversy over the utility of IV fluid preload. Uterine
displacement is common. Despite these precautions, it is
frequently necessary to administer a vasopressor. Ephedrine
effectively demonstrated effectiveness in restoring maternal
arterial pressure following hypotension and is typically
prescribed in such cases.1
Ketamine increases the release and inhibits the reuptake of
catecholamines, thereby preserving arterial blood pressure
and vascular resistance, making it the optimal anaesthetic
agent for hypotensive conditions.2 The sympathetic
nervous system is stimulated by ketamine, which results
in an elevated heart rate (HR) and hypertension. It can
raise intraocular and intracranial pressures, and its use is
restricted in conditions where such an increase in pressure
could be harmful (eye injury, head trauma, vascular disease,
and hydrocephalus, for example).3
Shivering during surgery is a prevalent issue in anaesthesia
practice, resulting in discomfort and life-threatening issues
if not effectively controlled and prevented, especially
in cardiorespiratory patients. Surgical patients may
experience shivering for various reasons, including surgery,
anaesthesia, skin exposure in a cool operating room, and
receiving unwarmed fluids. Numerous pharmacological
and non-pharmacological methods exist to prevent and
treat this issue. Methods for preventing and treating
shivering include prewarming the patient for 15 min prior
to anaesthetic administration and administering modest
doses (e.g., ketamine, clonidine, pethidine, dexamethasone,
dexmedetomidine, tramadol, and magnesium sulfate).2
Therefore, beneficial analgesic effects can be achieved
without psychoactive side effects such as hallucinations
and blockade of excitatory synaptic activity caused by
loss of responsiveness associated with clinical ketamine
anaesthesia.4 However, subsequent research revealed
that ketamine exhibits several different molecular effects
and plays a role in the management of a wide range of
conditions, including acute and chronic pain, and rapidly
acting antidepressant.5
We hypothesize that ketamine decreases the incidence
of spinal-induced hypotension in cesarean delivery by a
ketamine sympathhomimetic effect.
This study aimed to determine the effectiveness of ketamine
infusion on hemodynamic parameters in patients undergoing
cesarean delivery after spinal anaesthesia.
Methods
We included 126 female patients, aged 21-41 years,
undergoing cesarean deliveries with an American Society of
Anesthesiologists (ASA)-(II and III). Subjects were recruited
from the outpatient clinics of the Anaesthesia Department
Outpatient Clinics in Al-Azhar University Hospitals from
September 2022 to February 2023. Patients were randomly
assigned to two groups; Group K (63 patients), who received
0.3 mg kg-1 of ketamine IV diluted to 10 mL, followed by
an infusion of 0.1 mg kg-1 h-1 as 20 mL solution. Group C
(Controlled) (63 patients) received 10 mL of normal saline,
followed by an infusion of 0.1 mL kg-1 h-1 as a 20 mL solution.
The type of study: Randomized, double-blind, prospective,
controlled study.
Study Outcomes
Primary outcomes: Hemodynamic parameters (MAP and
HR).
Secondary outcomes
1. Incidence of intraoperative shivering
2. Postoperative pain was assessed by VAS score.
3. Sedation score between groups.
4. Fetuse evaluated using the Apgar score.
5. Postoperative side effects include nausea, vomiting,
nystagmus, diplopia, and hallucinations.
Ethical Considerations
The Research Ethics Committee approved the study protocol
at Al-Azhar University (approval no: 00328/2022). Written
informed consent was obtained from each patient before the
operation. This research is registered in the Clinical Trials
Register (NCT05865080).
Inclusion criteria
Female patients and full-term, between (21 and 40), with
(ASA)-II or III, and undergoing a cesarean section.
Exclusion criteria
1. Twins and preterm birth.
2. Hypertensive and preeclamptic patients.
3. Morbidly obese patients.
4. Spinal anaesthesia contraindication because the patient
refused severe mitral or tricuspid stenosis and local sepsis.
Randomization
Ten minutes before the start of anaesthesia, the patients
were equally randomized into two groups using computer-
generated random numbers placed in separate opaque
envelopes. The researcher opened the envelopes immediately
before administering spinal anaesthesia, as depicted in the
consort chart (Figure 1). An anaesthetist blinded to the study
groups prepared two syringes, one containing ketamine (5
mg mL-1, Ketalar, Pfizer, New York) and the other containing
0.9% saline. Both syringes were labeled “study drug” to
maintain the double-blind design of the study.
Turk J Anaesthesiol Reanim 2023;51(5):420-426 Aboelsuod et al. Ketamine Infusion on Hemodynamics for Patients Undergoing Cesarean Delivery
422
Anaesthetic procedure:
All patients underwent preoperative planning before surgery,
which included history taking, tests, and examinations. The
patient was connected to standard monitoring devices such
as noninvasive arterial blood pressure, electrocardiogram,
and pulse oximeter, with baseline parameters measured and
recorded in the pre-operative holding area. A wide-pore IV
cannula was placed with preoperative Ringer lactate (500
mL) as preload. No pre-medical treatment was administered.
At the L4-5 level, spinal anaesthesia was administered using
a paramedian approach while seated. A 25 G Quinke needle
and 2 mL of 0.5% heavy bupivacaine mixed with 25 g of
fentanyl were used. A 2-liter nasal cannula was used to
connect all patients. Ketamine was administered prior to the
administration of spinal anaesthesia and was discontinued
at the end of surgery.
Surgical procedures
Before administering spinal anaesthesia, the obstetrician
and nurse disinfected their hands with betadine and
sterilized the patient. The assessment of the patient’s lower
limb motor block and bilateral loss of sensation with a
pinprick to the T4 dermatomes indicated that the patient
had adequate surgical anaesthesia. After ensuring the
absence of sensation, the operation began, and the newborn
was evaluated at 1 and 5 min using the Apgar score by
the pediatrician. Following delivery and clamping of the
umbilical cord, oxytocin was administered. According to
the obstetrician’s recommendation, incremental doses of 10
units of oxytocin were administered, followed by increments
of 2 units, depending on the contractility of the uterus. After
completion of the operation, the patient was transferred to
the recovery room.
Measurements
1. The baseline data included the duration of the procedure,
the patient’s height, weight, age, gestational age, and an
indication of the cesarean section.
2. Intraoperative hemodynamics.
3. Incidence of shivering among groups.
4. Evaluation of sedation by Ramsay sedation score at 5, 10,
20, 30, and 40 min after surgery.
5. At four, eight, twelve, sixteen, twenty, and twenty-four
hours, the visual analog scale (VAS) was evaluated.
6. Fetus Apgar score in the 1st and 5th min.
7. Postoperative side effects, such as nausea, vomiting,
nystagmus, diplopia, and hallucinations.
Ramsay sedation score
1. Anxious, agitated, and restless.
2. Oriented, tranquil.
3. Responds to commands.
4. Brisk response to light glabellar tap.
5. Sluggish response to light glabellar tap.
6. No response (deep sedation).
Sample size justification
Using Epi-info TM version 7.2.4.0 (2020), the sample size
was determined on the basis of the following factors:
• Level of tow-side confidence: 95%
• 80% of the test power.
• 5% error rate.
According to the findings of the study by Salah and
Alansary6 on hemodynamic affection, a minimum sample
size of 140 subjects was required, plus an additional 15%
(or approximately 24 patients) to account for dropouts.
Therefore, the study included 63 patients in each group to
test the hypothesis.
Statistical Analysis
The collected data were coded, processed, and analyzed
using SPSS (Version 25) for Windows. Descriptive statistics
were calculated to include mean, standard deviation,
median, range, and percentage. For continuous variables,
independent t-tests were performed to compare the means
of normally distributed data. The Mann-Whitney U test was
used to compare the median differences in non-normally
distributed data, whereas the chi-square test was used for
categorical data. The t-test and Wilcoxon signed-rank test
were used for independent groups. The level of statistical
significance was set at P values <0.05.
Results
One hundred forty patients passed the eligibility criteria.
There were 14 patients excluded from the exclusion criteria.
A total of 126 patients were randomly assigned to two
groups, as depicted in the CONSORT flowchart (Figure 1).
There were statistically significant differences between
the groups with regard to age, weight, ASA, gestational
age, height, length of the procedure, and an indication of
cesarean section (P > 0.05) as shown in Table 1.
According to Tables 2 and 3, there were statistically
significant differences between the groups in terms of HR
and blood pressure (P < 0.05), with the ketamine groups
exhibiting greater hemodynamic stability.
There were statistically significant differences between the
groups regarding intraoperative sedation and the frequency
of shivering (P < 0.05), as depicted in Table 4. There were
statistically significant differences between the groups in
terms of pain score (VAS) postoperatively, which was lower
in the ketamine groups (P < 0.05), as illustrated in (Table 5).
Turk J Anaesthesiol Reanim 2023;51(5):420-426Aboelsuod et al. Ketamine Infusion on Hemodynamics for Patients Undergoing Cesarean Delivery
423
There were statistically significant differences between
the groups in terms of hypotension, nausea, and vomiting
(Figure 1).
There was no significant difference between the groups in
terms of nystagmus, diplopia, hallucinations, or neonatal
outcomes (P > 0.05) with respect to postoperative side
effects, as demonstrated in (Figure 2).
Table 1. Basic Data on the Study Population
Parameters Group K (n = 63) Group C (n = 63) P value
Age (years) 29.12±2.9 27.25±3.16 0.35
GA (weeks) 38±1.15 37±1.25 0.27
Weight (kg) 8 2±5.43 88±6.74 0.45
Height (cm) 155±8.68 158±2.53 0.17
ASA (II: III) 49:14 45:18 0.25
Duration of operation (mean ± SD) 45.44±7.76 51.65±5.48 0.23
Indication Previous CS: failed induction: Cephalopelvic Disproportion 28:10:25 32:12:19 0.55
Data represented by (mean ± SD), numbers and percentage.
Group K: Received ketamine. Group C: Received normal saline.
Table 2. Heart Rate Changes at Different Time (Mean ± SD)
in (b min-1)
Group
Time
Group K
(n = 63)
Group C
(n = 63)
P
value
Baseline 78.2±7.2 72.1±9.5 0.43
10 min 105.8±8.6 94.2±5.9 0.04*
20 min 114.5±6.2 85±5.7 0.02*
30 min 99.5±7.6 83.6±3.1 0.04*
40 min 93.5±5.6 81.6±5.31 0.16
40 min 89.5±7.3 86.6±2.7 0.32
At the end 86.5±6.8 80.7±6.5 0.24
*Statistically significant at P value ≤ 0.05.
Group K: Received ketamine. Group S: Received normal saline.
Table 3. Mean Arterial Blood Pressure Changes (Mean ± SD)
in mmHg
Group
Time
Group K
(n = 63)
Group C
(n = 63) P value
Baseline 85.7±7.2 88.1±6.8 0.51
10 min 115.5±8.6 65.3±5.6 0.02*
20 min 90.7±6.4 75.2±7.4 0.004*
30 min 98.7±5.9 83.2±5.4 0.002*
40 min 89.7±5.9 76.2±7.1 0.34
50 min 92.7±5.9 81.2±8.5 0.25
At the end 82.3±5.7 87.2±7.1 0.12
*Statistically significant at P value ≤ 0.05.
Group K: Received ketamine. Group S: Received normal saline
Table 5. Postoperative Pain Score (VAS) Between Two Groups
Groups
Parameter
Group K
(n = 63)
Group C
(n = 63) P value
2 hrs. 1 (0-1) 0 (0-1) <0.01*
4 hrs. 2 (2-3) 1 (1-2) <0.05*
8 hrs. 3 (2-3) 2 (1-2) <0.05*
12 hrs. 4 (3-4) 3 (1-2) <0.01*
16 hrs. 5 (4-5) 4 (2-4) <0.05*
20 hrs. 5 (4-5) 4 (4-5) 0.13
24 hrs. 6 (5-6) 6 (5-6) 0.12
Data represented by (IQR).
*Statistically significant at P value ≤ 0.05.
Group K: Received ketamine. Group C: Received normal saline.
Table 4. Sedation Scores and Number of Patients with
Shivering
Groups
Parameters
Group K
(n = 63)
Group C
(n = 63)
P
value
Minute-5 4 (3-4) 2(1-2) <0.01*
Minute-10 4 (3-4) 2 (1-2) <0.01*
Minute-15 3 (3-4) 3 (2-3) <0.01*
Minute-30 3 (2-3) 2 (1-2) 0.17
Minute-45 2 (1-2) 1 (1-2) 0.11
End 2 (1-2) 1 (1-2) 0.13
Number of patients with
shivering 5 (7.94%) 22 (38.1%) <0.001*
Data represented by (IQR), numbers and percentage.
*Statistically significant at P value ≤ 0.05.
Group K: Received ketamine. Group S: Received normal saline.
Turk J Anaesthesiol Reanim 2023;51(5):420-426 Aboelsuod et al. Ketamine Infusion on Hemodynamics for Patients Undergoing Cesarean Delivery
424
Discussion
Spinal anaesthesia applications, particularly during cesarean
section in pregnant women, have been found to cause both
hypotension and tremor with sympathetic blockade and are
accompanied by some complications. This study avoided
the common adverse effects associated with obstetric
anaesthesia.
When compared with the control group, the ketamine
patients in the current study demonstrated hemodynamic
stability in terms of mean blood pressure and HR (P < 0.05).
These findings agree with those of Salah and Alansary6
study, which reported that a minimal amount of ketamine
could be used to prevent hypotension following intrathecal
anaesthesia in CS.
With a frequency of between 40% and 60% in patients
undergoing surgery, perioperative shivering is a severe
adverse effect frequently following neuraxial anaesthesia.
In particular, in patients with cardiorespiratory issues, it
causes excruciating discomfort and negative outcomes.
Many techniques have been devised to avoid and manage
shivering during and after neuraxial anaesthesia.7,8
In spinal anaesthesia, hypotension is caused by sympathetic
nervous system blockade, and aortic and inferior vena cava
compression during pregnancy is typically treated with
ephedrine, intravenous fluid, and left lateral tilt.9
In the present study, 38.1% of patients in the saline group
experienced postoperative shivering, compared with
7.94% in the ketamine group. The percentage of patients
recovering from anaesthesia who experienced postoperative
shivering ranged from 5-65%,10 and numerous studies have
reported that ketamine plays a role in reducing postsurgical
shivering.11
Thangavelu et al.,12 reported that only 4 cases (13.79%)
of intraoperative shivering were observed in the ketamine
group compared with 80 cases (58.06%) in the group
receiving saline. In addition, the ketamine group showed
significantly less postoperative shivering than the saline
group. A small bolus of low-dose ketamine followed by
an infusion prevented intraoperative and postoperative
shivering. In the current study, intraoperative sedation was
superior in the ketamine group compared with that in the
control group. Also postoperative analgesia was better in the
ketamine group than in the control group. Brinck et al.13
studies on intravenous ketamine during surgery to treat
severe postoperative pain in adults revealed a reduction in
opioid dependance (an average decrease of 14.38 mg of
intravenous morphine equivalents in 24 h).
Pendi et al.,14 studies on patients who underwent spine surgery
using perioperative ketamine as an analgesic and found that
it reduced opioid-related side effects such as postoperative
nausea and vomiting and respiratory sedation and
improved engagement in recovery-oriented activities such as
postoperative physiotherapy. In this study, there were significant
differences in VAS between the groups postoperatively, with
the ketamine group experiencing prolonged analgesia. These
findings are consistent with those of Seman et al.,15 studies in
patients with morbid obesity undergoing laparoscopic gastric
bypass surgery. They reported that infusions of ketamine
significantly reduced the need for opioids in the ketamine
group compared with the control group.
In the current study, 8 (14.28%) patients in the ketamine
group and 18 (60.32%) patients in the saline group
experienced nausea and vomiting. Nystagmus was reported
in four patients (6.3%), diplopia in six (9.5%) patients and
hallucinations in seven patients (11.11%) in the ketamine
group, but none of these side effects were reported in the
saline group. In more than 80% of cases, the most frequent
side effect of intrathecal anaesthesia is hypotension, which
Figure 1. CONSORT diagram chart
Figure 2. The two groups’ side effects.
Turk J Anaesthesiol Reanim 2023;51(5):420-426Aboelsuod et al. Ketamine Infusion on Hemodynamics for Patients Undergoing Cesarean Delivery
425
can negatively impact uterine blood flow and the health
and outcome of the fetus as measured by Apgar scores.16 In
the compared groups of this study, Apgar scores remained
unchanged.
Adhikari et al.,17 illustrated that in patients who undergo
nonelective cesarean deliveries, intravenous administration
of a small dose of ketamine before surgical incision
significantly decreases the need for opioid usage in the first
24 h post-surgery.
Karacaer et al.,18 reported that a continuous infusion of
ketamine and deflurane inhalation in patients with chronic
obstructive pulmonary disease during one-lung ventilation
increased arterial oxygenation and decreased shunting by
ketamine effect on the catecholamine reuptake inhibitor
mechanism. Therefore, there was no risk of respiratory
depression when using a small dose of ketamine, and there
were no cases of desaturation.
In this study, the incidence of mild or severe hypotension
was significantly lower in the ketamine group than in the
saline group.
Dhiman et al.,19 reported that a small nebulized dose of
ketamine with dexmedetomidine was superior to sedation
with enhanced ease of intravenous line and postoperative
analgesia in children.
Ketamine increases the release and inhibits the reuptake
of catecholamines in circulation, thereby aiding in the
preservation of vascular resistance and arterial blood
pressure, making it the optimal anaesthetic method for
hypotensive patients.20
Numerous clinical and pharmacological properties of
ketamine have recently been reported. There are numerous
applications of ketamine in anaesthesia, pain management,
and intensive care.21
Intravenous low-dose ketamine combined with midazolam
for sedation during spinal anaesthesia for elective cesarean
section provides more effective and long-lasting pain relief
than the control group.22
Spinal anaesthesia applications, especially during cesarean
section in pregnant women, cause both hypotension and
tremor with sympathetic blockade and result in many
complications. This study will provide an opportunity to
avoid undesirable effects frequently encountered in obstetric
anaesthesia.
Study Limitations
In this research, the study was conducted on some cases, and
patient satisfaction was not evaluated.
Conclusion
Ketamine decreases the incidence of hypotension and
shivering in patients undergoing spinal anaesthesia during
cesarean delivery. In addition, it resulted in improved
sedation for the mother and prolonged postoperative
analgesia without neonatal illness.
Ethics Committee Approval: The Research Ethics Committee approved
the study protocol at Al-Azhar University (approval no: 00328/2022).
Informed Consent: Written informed consent was obtained from each
patient before the operation.
Author Contributions: Concept - M.A.A.A.; Design - M.M.H.A.;
Supervision - T.A.A.A.A.; Fundings - M.A.A.A.; Materials - M.I.A.E; Data
Collection and/or Processing - A.S.A.E.; Analysis and/or Interpretation -
M.M.H.A.; Literature Review - A.M.A.E.; Writing - T.A.A.A.A.; Critical
Review - A.M.A.E.
Declaration of Interests: Nil
Funding: Nil
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