Conditions: Emergence Delirium
Keywords: Emergence Agitation Dexmedetomidine Delirium Children Facial Cleft
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 121
Healthy volunteers: yes

Brief summary:
Emergence agitation is commonly encountered after receiving inhalation anesthesia. This distressing phenomenon carries risks that are harmful to patients, caregivers and medical personnel. Using total intravenous Dexmedetomidine, the investigators seek to reduce agitation and provide gentle emergence from anesthesia.

Detailed description:
Surgery for pediatric cleft lip and palate repair often utilizes high dose opioids and inhaled anaesthesia, thereby causing postoperative complications such as desaturation and/or severe agitation after anesthesia. These complications are detrimental to the child, medical personnel and causes tremendous psychologic stress to parents. This study aims to decrease these complications through Dexmedetomidine, an Alpha-2 receptor agonist with anxiolytic, sympatholytic and analgetic properties. Devoid of respiratory depressant effect, it allows patients to maintain effective ventilation and reduce agitation, postoperatively. Its unique anesthetic property may shed light to provide safe anesthesia and gentle emergence to this young, vulnerable population.

Arms:
arm 1: Participants in this group will receive inhalation anesthesia Sevoflurane at 2-3 Vol% as their sole anesthetic maintenance agent throughout the surgical procedure. arm 2: Participants in this group will receive Total Intravenous Dexmedetomidine as their sole anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour will be given throughout the surgical procedure.

Interventions: intervention 1: Dexmedetomidine intervention 2: Sevoflurane
Intervention descriptions: intervention 1: Intervention group will receive Total Intravenous Dexmedetomidine as their anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour continued as the sole anesthetic maintenance agent, thereafter. intervention 2: Inhalation Sevoflurane will be administered as an anesthetic maintenance agent. Sevoflurane at 2 - 3 Vol% will be administered throughout the operative procedure.

Protocol document:
Prot_SAP_000.pdf: 
 
 
1 
 
Study Protocol and Statistical Analysis Plan for Research Project:  
 
“Emergence Agitation in Pediatrics after Dexmedetomidine vs. 
Sevoflurane Anesthesia: a randomized controlled trial” 
 
 
Clinicaltrials.gov # NCT06482125 
 
 
Conducted by Corry Quando Yahya, MD, Hori Hariyanto MD, PhD, Kohar Hari 
Santoso MD, PhD, Lucky Andriyanto MD, Arie Utariani MD, PhD, Bambang Pujo 
Semedi MD, PhD, Elizeus Hanindito MD, PhD 
July 1, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
2 
 
1. 
ABSTRACT 
BACKGROUND 
Emergence Agitation (EA) is a common occurrence in pediatric 
anesthesia. (1) The incidence has been reported to vary from 10% to 
as high as 80% after being exposed to inhalation anesthesia, 
particularly Sevoflurane. Maladaptive behaviors such as kicking, 
screaming, and thrashing are seen during agitation and contributes to 
postoperative complications such as tongue edema, re-bleeding of 
surgical wounds, falling out of bed, accidental removal of the 
intravenous line, bronchospasm and wound dehiscence. Anesthesia 
using Sevoflurane remain the main choice for cleft lip and cleft palate 
(CP) surgeries in children at the current moment. (1–3) As a result, 
majority of these children experience intense agitation after 
recovering from anesthesia.  
 
OBJECTIVES 
We propose a randomized controlled trial comparing emergence agitation 
in patients receiving Sevoflurane inhalation versus intravenous 
Dexmedetomidine infusion.  
 
Primary Hypotheses: 
The use of intravenous Dexmedetomidine reduces emergence agitation to 
children after anesthesia. 
 
METHODS 
All children enrolled to undergo an elective cleft lip or palate surgery at 
Pelita Harapan University and Siloam Hospital Lippo Village who fulfill 
the inclusion criteria will be selected. 
 
2. SPECIFIC AIMS 
 
Aim #1. To measure and compare emergence agitation between 
Sevoflurane and Dexmedetomidine group.  
Aim #2. To measure and compare time to extubation between 
Sevoflurane and Dexmedetomidine group. 
Aim #3: To measure and compare time to full recovery between 
Sevoflurane and Dexmedetomidine group. 
Aim #4: Report any adverse events or side effects in both groups.  
 
3. STUDY DESIGN 
• A randomized controlled trial, single-blinded. 
• Allocation: Simple Randomized (1:1) Patients are selected randomly 
using a computer-generated device to become a control arm 
(Sevoflurane) or treatment arm (Dexmedetomidine) 


 
 
3 
 
• Number of Arms: 2 (Sevoflurane vs. Dexmedetomidine) 
• Masking: Single (Participant) 
 
4. STUDY POPULATION 
Children ages 3 months to 120 months (10 years) scheduled for an 
elective cleft lip or palate surgery in Pelita Harapan University and 
Siloam Hospital Village, Tangerang, Indonesia. 
 
5. ELIGIBILITY TO PARTICIPATE ON THE STUDY 
 
Minimum Age: 
 
 3 months   
Maximum Age: 
 
 10 years   
Sex:  
 
 
All   
Gender Based: 
 
No   
Accepts Healthy Volunteers: Yes   
 
Criteria: 
 
Inclusion Criteria: 
➢ Patients with weight ranging 5 kg - 25 kg 
➢ Patients with American Society of Anesthesiologist (ASA) 
Physical Status Classification 1 and 2 
Exclusion Criteria: 
➢ Patients with any acquired congenital syndrome 
➢ Patients who are actively taking anti-seizure medications and/or 
has been diagnosed with epilepsy 
➢ Patients with functional and structural abnormalities of the heart, 
including arrythmias 
➢ Patients with liver disease 
 
6. RECRUITMENT 
All children admitted to undergo an elective cleft lip or palate surgery 
between July 31, 2024 up to December 1, 2024. 
 
7. DATA COLLECTION AND MEASURES 
Data will be measured and collected starting July 31, 2024 up to 
December 1, 2024.  
 
8. QUALITY ASSURANCE AND QUALITY CONTROL 
Preoperative assessment and randomization of group type was 
performed one day before the operation.  
 
 
9. RANDOMIZATION AND MASKING 
A computer-generated random array sealed and envelope 


 
 
4 
 
method was employed to divide enrolled pediatric patients into two 
groups 
by 
simple 
randomization 
(1:1 
ratio 
allocation). 
Experimental medication was prepared and provided by research 
staff who were not directly involved in patient care, while the 
surgeon, anesthesiologist and participating families were blinded 
to the medication distribution and group allocation.  
On the day of surgery, the anesthesiologist responsible of the 
case was informed on each child’s allocation and gave medications 
according to their designated groups. Agitation scale upon 
awakening and extubation time were recorded by a nurse anesthetist 
inside the operating room; while agitation monitoring every fifteen 
minutes were carried out by a different nurse in the recovery room 
without prior knowledge of the child’s group allocation. 
 
10. 
INTERVENTIONS 
Anesthesia was administered using inhalation of 8% 
Sevoflurane in 100% oxygen until an intravenous line was secured. 
All patients were given Fentanyl 2 micrograms/kg, Propofol 
3mg/kg and an oral endotracheal intubation of appropriate size was 
secured. After intubation, patients in Group DEX stopped receiving 
Sevoflurane. Dexmedetomidine infusion using an intravenous line 
was started at a loading dose of 1.5ug/kg for 10 minutes, followed 
by a maintenance dose of 1.5ug/kg/hour via a syringe pump while 
patients in Group SEVO continued receiving Sevoflurane at a 
concentration of 2-3 vol%.  
All patients maintained spontaneous ventilation throughout the 
intraoperative period. Analgesia was supplemented with local 
anesthetic infiltration at the surgical site and intravenous 
Paracetamol 15mg/kg given 10 minutes before the end of surgical 
procedure. At the end of surgery, Dexmedetomidine infusion was 
stopped in group DEX and Sevoflurane inhalation was stopped in 
group SEVO: every one of them was extubated and moved to the 
post-anesthesia care unit for postoperative monitoring. 
 
 
 
 


 
 
5 
 
Fig 1. Flowchart of patient selection and grouping 
 
11. 
SAFETY MONITORING 
➢ Potential risks : bradycardia, hypotension, hypertension 
➢ Alert values: Patients are continually monitored using standard 
monitoring which includes an electrocardiograph (ECG), non-
invasive blood pressure and peripheral oxygen saturation 
(SpO2) which were recorded starting from induction and every 
5 min, thereafter. Monitoring of anesthestic depth was ensured 
using SEDLine™ monitor, Masimo Corporation, Irvine, CA, 
USA to measure processed electroencephalograph or Patient 
State Index (PSI). Throughout the procedure, all patients 
retained their spontaneous respiration while maintaining their 
PSI value between 25-50. 
➢ Reporting Procedures: written on a paper during research. 


 
 
6 
 
Preoperative 
anxiety 
status 
will 
be 
assessed 
by 
an 
anesthesiologist, the day before surgery. Time to extubation and 
agitation scale upon awakening will be recorded by the nurse 
anesthetist assisting the anesthesiologist on the day of operation. 
After transferring the child to the recovery room, another nurse 
will assess their agitation scale every 15 minutes using Cravero 
agitation scale. All these values are inputted on a computer after 
completion of anesthesia procedure, at the end of the day by a 
research staff who is not involved in patient care. 
 
12. STATISTICAL POWER AND SAMPLE SIZE 
ESTIMATION 
 
This study compares the incidence of agitation between the Sevoflurane 
group and the Dexmedetomidine group. This study is a categorical data, 
so the sample formula uses the formula: 
 
 
 
 
Dexmedetomidine (p1) versus Sevoflurane (p2) anesthesia were 
analyzed with p1 being 10% and p2 being 40% with a power of 0.8 and 
alpha of 0.05. The power analysis study yielded sample size of 35 
patients in each group. Considering 20% dropout case, we needed 42 
cases per group and a total of 84 cases. Results were expressed as range 
(median), mean ± standard deviation, or number (%). 
 
13. ANALYSIS PLAN 
Missing and Incomplete data will be reported, if there are any. 
 
14. DATA MANAGEMENT 
Data confidentiality is ensured as all data are secured and locked in our 
institution. Access is only granted to the researchers involved. 
 
15. TRIAL ADMINISTRATION -  HOW INVESTIGATORS/STAFF 
WILL BE ORGANIZED 
➢ The surgeon, anesthesiologist and participating families were blinded 
to the medication distribution and group allocation.  
➢ After preoperative assessment and patient met the inclusion criteria, 
patients or the patient’s family chose an envelope with a number inside 
it. The selected number later specified whether the patient was a control 
group or a treatment group, as randomized by the computer with 1:1 
ratio allocation. 


 
 
7 
 
➢ Experimental medication was prepared and provided by research staff 
who were not directly involved in patient care for use the following 
day that surgery took place. On the day of operation, the 
anaesthesiologist responsible in anesthetizing the child will be 
informed of the child’s group allocation in order to provide the 
appropriate medication according to their designated groups. The 
surgeon and recovery room nurse were not informed of the child’s 
group allocation. 
 
16. TIMELINE 
➢ Research data gathering will be performed starting July 31, 2024 up to 
December 31, 2024. 
➢ Data processing will start from January 1, 2025 to February 28, 2025. 
➢ Research writing is expected to be completed at July 1, 2025. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
8 
 
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Appendix 1. Modified Yale Preoperative Anxiety Scale (mYPAS) 1 
  
SCORE 
Behavior 
1 
2 
3 
4 
5 
6 
Activity 
Looking around, curious, 
playing with toys, read 
ing (or other age-appropriate 
behavior); moves around  
holding area/treatment room to 
get toys or go to parent;  
may move toward OR 
equipment. 
Not exploring or 
playing, may look 
down, may f idget with 
hands or suck thumb 
(blanket); may sit close 
to parent while 
waiting, or play has a 
definite manic quality. 
Moving from toy to parent 
in unfocused manner, 
nonactivity-derived 
movements; 
frenetic/frenzied movement 
or play; squirming, moving 
on table, may push mask 
away, or clinging to parent. 
 Actively trying to get 
away, pushes with feet 
and arms, may move 
whole body; in waiting 
room, running around 
unfocused, not looking 
at toys or will not sepa 
rate from parent, 
desperate clinging. 
  
  
Vocalization 
Reading (nonvocalizing 
appropriate to activity), asking 
questions, making comments, 
babbling, laughing, readily 
answers questions but may be 
generally quiet; child too 
young to talk in social 
situations or too engrossed in 
play to respond. 
Responding to adults 
but whispers, “baby 
talk,” only head 
nodding. 
Quiet, no sounds or 
responses to adults. 
Whimpering, moaning, 
groaning, silently 
crying. 
Crying or 
may be 
screaming 
“no.” 
Crying, 
screaming 
loudly, 
sustained 
(audible  
through 
mask) 
Emotional 
Expressivity 
Manifestly happy, smiling, or 
concentrating on play. 
Neutral, no visible 
expression on face. 
Worried (sad) to 
frightened, sad, worried, or 
tearful  
eyes. 
Distressed, crying, 
extremely upset, may 
have wide eyes. 
  
  
State of 
apparent 
arousal 
Alert, looks around 
occasionally, notices or 
watches what anesthesiologist 
does with him/her (could be 
relaxed). 
Withdrawn, child 
sitting still and quiet, 
may be sucking on 
thumb or face turned 
into adult. 
Vigilant, looking quickly 
all around, may startle to 
sounds, eyes wide, body 
tensed. 
Panicked whimpering, 
may be crying or 
pushing others away, 
turns away 
  
  
 


Scoring produce 4 mYPAS scores (1 for each behaviour). Each score is calculated by dividing each item rating by the highest possible rating (i.e., 
6 for the “vocalizations” item and 4 for all other items), adding all the produced values, dividing by 4 and multiplying by 100. This calculation 
produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety. In this study, the cutoff value of anxiety is taken from 
study by Eko et al2 which reported a score of 29 to be non-anxious children; while a mYPAS score of  ≥ 29 is considered as children who are 
anxious. 
Example 1: 
Activity = 1/4 = 0.25 
Vocalization = 1/6 = 0.16 
Emotional Expressivity = 1/4 = 0.25 
State of apparent arousal = 1/4 = 0.25 
Total points = (0.25 + 0.16 + 0.25 + 0.25) / 4 = 0.2275 
Multiply by 100 = 0.2275 x 100 = 22.75% 
 
Example 2: 
Activity = ¾ = 0.75 
Vocalization = 3/6 = 0.5 
Emotional Expressivity = 2/4 = 0.5 
State of apparent arousal = 2/4 = 0.5 
Total points = (0.75 + 0.5 + 0.5 + 0.5) / 4 = 0.56 
Multiply by 100 = 0.56 x 100 = 56% 
 
 
 
 
 
 
 
 
 
 
 


Appendix 2. CRAVERO SCALE 3 
 
Measurements are taken starting from extubation and repeated every 15 minutes until patient regain full consciousness or completely awakened. 
 
For example: 
Cravero Scale at extubation = 3 (at the operating theatre) 
At the recovery room area: 
Cravero Scale at 15 min = 4  
Cravero Scale at 30 min = 4 
Cravero Scale at 45 min = 4 
Cravero Scale at 60 min = patient awakened 
Hence, the average Cravero scale is (3+4+4+4)/4 = 3.75 (Classified as agitated) 
Time to complete awakening is 60 minutes. 
 
 
1. Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 
Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350. PMID: 25010821. 
2. Prayunanto, Eko; Widyastuti, Yunita; Sari, Djayanti. The association of modified Yale perioperative anxiety scale and pediatric anesthesia behavior on postoperative 
emergence delirium in children: A prospective cohort study. Bali Journal of Anesthesiology 7(2):p 88-93, April-June 2023. | DOI: 10.4103/bjoa.bjoa_22_23 
3. Nair S, Wolf A. Emergence delirium after paediatric anaesthesia: new strategies in avoidance and treatment. BJA Educ. 2018 Jan;18(1):30-33. doi: 
10.1016/j.bjae.2017.07.001. Epub 2017 Nov 21. PMID: 33456792; PMCID: PMC7808066. 
Scale 
Behaviour 
1 
Obtunded with no response to stimulation 
2 
Asleep, but responsive to movement and/or stimulation 
3 
Awake and responsive 
4 
Uncosolable crying more than 3 minutes, without any combative 
behaviour 
5 
Unconsolable with thrashing and combative behavior such as kicking, 
pushing, arching back and/or pulling intravenous lines 
A scale of 1.0-3.0 = not agitated; Scale > 3.1-5.0 = agitated 

ICF_001.pdf: 
Informed Consent Form for Research Project:  
 
“Emergence Agitation in Pediatrics after Dexmedetomidine vs. Sevoflurane 
Anesthesia: a randomized controlled trial” 
 
 
Clinicaltrials.gov # NCT06482125 
 
 
Conducted by Corry Quando Yahya, MD, Hori Hariyanto MD, PhD, Kohar Hari Santoso 
MD, PhD, Lucky Andriyanto MD, Arie Utariani MD, PhD, Bambang Pujo Semedi MD, PhD, 
Elizeus Hanindito MD, PhD 
July 1, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Appendix 1. Research Explanation Sheet 
 
EXPLANATION SHEET TO THE SUBJECT CANDIDATE 
 
I, Corry Quando Yahya MD from the Department of Anesthesiology and Intensive Therapy, 
Pelita Harapan University and Siloam Hospital Lippo Village will conduct a study entitled 
Emergence Agitation in Pediatrics after Dexmedetomidine vs. Sevoflurane Anesthesia: a 
randomized controlled trial 
 
I will provide information to you about this research and invite your sons and daughters to be 
part of this research. You can participate in this study by signing this form. If you agree to 
participate in this study, you can freely withdraw from this study at any time. If you refuse to 
participate or withdraw from this study, the decision will not affect your relationship with me 
and will not affect the services that apply at this hospital. If you don't understand each statement 
in this form, please feel free to ask me. 
 
Research Objectives 
 
In this study, your son/daughter will be given an anesthetic agent called Dexmedetomidine 
through a vein. This drug aims to provide a sleeping effect to the child during the surgical 
procedure. Side effects of giving Dexmedetomidine as an anesthetic includes a decrease in 
blood pressure and a decrease in heart rate. If there are these side effects, your child will be 
given medication to increase blood pressure and heart rate.  
 
In this study, the time to recover from anesthesia and side effects such as agitation (restlessness) 
and decreased oxygen levels in the blood after anesthesia will be noted and compared with the 
administration of inhaled anesthetic (Sevoflurane). Through this research, we hope that your 
child will recover from anesthesia in a calm and gentle manner, in order to reduce 
complications from restlessness and in doing so may accelerate the healing process after 
surgery. 
 
Participation in research 
 
Overall, the study is expected to take place until the target number of subjects specified has 
been met (approximately 1 year study time frame). If you decide to participate in this study, 
your son or daughter will receive the drug Dexmedetomidine during his or her surgery. 
 
Reasons for choosing subject 
 
Your son/daughter was selected according to the criteria of this study, namely pediatric patients 
aged 2-5 years with an assessment of ASA 1 and 2 physical status (mild illness), have a good 
tolerance for enteral (oral) fluid, do not have hormonal system abnormalities and will undergo 
cleft lip or cleft lip surgery under general anesthesia. 
 
Research Procedure 


 
1. Identify research subjects to assess eligibility. 
2. Once the patient's parent or guardian has been provided with an explanation of the 
research procedure and agreed to participate in the study, the patient's parent or 
guardian will be asked to sign the consent. Identity and pre-surgical data are recorded. 
3. In the preoperative room, patients are assessed and they will be randomly assigned into 
2 groups: group X1 who will receive anesthesia with intravenous Dexmedetomidine 
and group X2 who will receive anesthesia using inhalation Sevoflurane. 
Dexmedetomidine or Sevoflurane will be the anesthetic maintenance agent used during 
the surgical process until it is completed. 
4. The patient fasts during the fasting protocol. The last solid meal is consumed up to 6 
hours before surgery, breast milk up to 4 hours pre-operatively and 2 hours for clear 
fluid such as water. 
5. Patient arrives in the preparation room of the operating theatre in accordance with their 
time of operation.  
6. In the operating room, saturation monitors, electrocardiography and non-invasive blood 
pressure monitors are installed. Each subject blood pressure and pulse rate were 
recorded from the time of induction. Induction is carried out with anesthesia standards 
using Sevoflurane inhalation until the child is asleep and an intravenous line is secured. 
Maintenance of anesthesia is carried out using Sevoflurane or Dexmedetomidine 
according to the child’s designated group. After surgery is completed, recovery time 
and the incidence of decreased blood oxygen levels or agitating events will be assessed 
into 
two 
groups. 
 
Risk 
Side effects and management of anesthesia are a decrease in blood pressure and a decrease in 
heart rate. Guidelines for such treatment are the administration of intravenous (IV) fluids and 
drugs to raise blood pressure and pulse. The drugs and IV fluids are always provided at every 
operation. 
 
Benefit 
This study will be the first study to evaluate the use of Dexmedetomidine as a maintenance 
anesthetic agent for children undergoing cleft lip and cleft lip surgery. 
 
Compensation 
There is no compensation or reward for participating in this study. 
 
Financing 
This research was fully funded by the researcher. 
 
Concealment 
All data collected in this study will be kept confidential. We will display the identity of each 
respondent in the form of initials and can only be accessed by the research team and the ethics 
committee for verification. Presentation of research results in scientific meetings/conferences 
and publications in scientific journals will not include the name of your child. 
 


Obligations of the research subject 
As a research subject, you are obliged to follow the rules or guidelines for research as written 
above. If something is not clear, you can ask further questions to the research team. 
 
Right to refuse and withdraw from the study 
You do not have to participate in this research if you do not want to. You must understand 
that even if you agree to participate, you have the right to withdraw from this research. If you 
refuse to participate or withdraw from this research, the decision will not affect your 
relationship with me and will not have an impact on the standard of service that applies to 
this hospital. I will give you an opportunity at the end of this explanation to be able to 
consider the decision to be made. 
 
Post-trial access 
None 
 
Additional Information 
You are given the opportunity to ask all the things that are not clear in relation to this research. 
If at any time you need further explanation, you can contact me, Corry Quando Yahya at my 
mobile number 081383190900. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Appendix 2. Research Participation Consent Sheet 
 
 
CONSENT SHEET FOR PARTICIPATION IN RESEARCH 
 
All these explanations have been presented to me and all my questions have been answered by 
the research team. I understand that if I need an explanation, I can ask Corry Quando Yahya, 
MD. 
 
Consent form 
I have read all the explanations about 
this research. I have been given the 
opportunity to ask questions and all 
my questions have been answered 
clearly. I am willing to participate in 
this research study voluntarily. I 
confirm that participants have been 
given the opportunity to ask questions 
about this study, and that all questions 
have been answered correctly. I 
confirm that consent has been given 
voluntarily. 
 
 
 
 
 
 
I confirm that the participants have 
been given the opportunity to ask 
questions about this study, and that 
all questions have been answered 
correctly. I confirm that consent has 
been given voluntarily. 
Subject Name / Guardian 
 
 
 
 
 
 
Researcher/ Consent Requester 
Signature of Guardian 
Signature of researcher/ Consent 
requester 
 
 
 
Date  
 Date  
 
Day/month /year 
Day/month/year 
Lead Researcher : Corry Quando Yahya, MD 
Jalan Palem Putri Raya No. 17A, Palem Semi, Tangerang 15810 
HP: 081383190900 
Email: corry.spa@gmail.com, corry.yahya@lecturer.uph.edu 
 


 
 
CONSENT SHEET 
 
 
 
I give consent to my child, with the name (_____________________________________) who 
participated in the study: Emergence Agitation in Pediatrics after Dexmedetomidine vs. 
Sevoflurane Anesthesia: a randomized controlled trial.  
 
I have read and understood the information contained in the information sheet and have been 
given the opportunity to discuss and ask about it. I agree to allow my child to receive treatment 
according to the research protocol. I understand that I can refuse to participate in research. I 
am aware that I can withdraw from this research at anytime I desire to do so. I understand that 
if I do not participate in this study, my child will still receive medical care that is appropriate 
for his or her condition. 
 
I, as the PARENT/GUARDIAN of : __________________________________________ 
 
AGREE to participate in this research. 
 
Date:.________________________________________________________________ 
 
Parent/Guardian Signature : _____________________________________ 
 
Parent/Guardian Name : .________________________________________ 
 
Signature of Witness : ___________________________________________ 
 
Name of Witness: ______________________________________________ 
 
 
 
 
 
 
 
 
 
 
 


Appendix 3. Consent Sheet for Publication 
 
PUBLICATION AGREEMENT 
I give my consent for the material about me/the patient to appear in a journal that my researcher 
will submit to. 
I confirm that I: (please check to confirm) 
o have viewed photos, images, text or other material about me/the patient 
o have read an article to be submitted to a journal 
o I am legally entitled to give this consent. 
 
I understand the following: 
(1) The material will be published without my name/patient attached, however I understand 
that complete anonymity cannot be guaranteed. It is possible that someone somewhere – for 
example, someone who is caring for me/a patient or a relative – may recognize me/the patient. 
(2) The material may show or include details of my / patient's medical condition or injury and 
the prognosis, treatment or surgery of any I/patient has, has or may have in the future. 
(3) Articles will be published in journals distributed worldwide. 
 (4) Articles, including materials, may be the subject of press releases, and may be linked 
to/from social media. Once published, the article will be placed on the publisher's website and 
may also be available on third-party websites. 
(5) I/the patient will not receive any financial benefits from the publication of the article. 
(6) I can revoke my consent at any time before the author submits the article to the journal, but 
once the article is committed to peer review, it will not be possible to revoke consent. 
 
Signature (Parent or Guardian) 
Name 
 
Date 
 
Relationship to 
subject 
 
Details of the person who has explained and provided the form to the patient or 
representative. 
Signature (Lead Researcher) 
Name 
Corry Quando Yahya 
Date 
 
Correspondence 
address 
Jln. Palem Putri Raya No 17A, Palem Semi – Tangerang 15811 
Email 
Corry.spa@gmail.com; corry.yahya@lecturer.uph.edu