Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel- a Single-blinded Randomized Controlled Trial.
Phase: NA
Conditions: Dental Caries in Children, Anesthesia, Local, Injection Site Discomfort
Sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences

 
 
 
2023 
RESEARCH PROTOCOL 
25.04.2023 
      

 
 
RESEARCH PROTOCOL 
STUDY TITLE:  
Efficacy of Ethyl Chloride topical anesthesia application on the pain 
perception during intra-oral injections in children in comparison to 20% 
Benzocaine Gel– a single-blinded randomized controlled trial 
 
STUDY INVESTIGATOR: 
 
Principal Investigator:   
Dr. Nagah Abdelrahman 
Pediatric Dentistry Resident 
Phone: +971 551225599 
Email: Nagah.Abdelrahman@residents.mbru.ac.ae    
 
STUDY SUPERVISORS: 
 
Principal Supervisor:  
Dr. Anas Al Salami                                                         
Assistant Professor - Pediatric Dentistry                                                  
Phone: +971 43838928                                                                     
Email: Anas.AlSalami@mbru.ac.ae  
       
Co Supervisors:  
Dr. Manal Al-Halabi                          
 
 
Professor - Pediatric Dentistry           
Phone: +971 55 5510564                                                       
Email: manal.halabi@mbru.ac.ae  
 
 
 Dr. Mawlood Kowash 
Professor - Pediatric Dentistry           
Phone: +971 50 5939004 
Email: mawlood.kowash@mbru.ac.ae 
 
Dr. Iyad Hussein                                                
Associate Professor - Pediatric Dentistry 
Phone: +971 43838907 
Email: iyad.hussein@mbru.ac.ae 
 

 
Co - Investigator:   
Dr. Aysha Alshamsi                                                
Pediatric Dentistry Resident 
Phone: +971 553576666 
Email: Aysha.AlShamsi @residents.mbru.ac.ae  
 

 
1. Introduction 
 
Fear of the syringes and needle insertion is high among children. Reducing injection pain in 
children may help to provide overall comfort and well-being during the entire dental 
experience. Pediatric dentists are constantly searching for tools that may provide a more 
comfortable dental procedure. 1  A local anesthetic injection is one of the potent techniques to 
alleviate pain, but injection of local anesthetic itself is a major source of patient’s fear. 2  
The challenge is to find an effective method that can be utilized in the pediatric population. 
Topical anesthetics function by blocking signal transmission in the terminal fibers of sensory 
nerves. Their effects are limited to the control of painful stimuli occurring in or just beneath 
the mucosa. 3 
Over the years, topical anesthetics have been used consistently in dentistry to prepare injection 
sites before needle penetration. Some studies have proved topical anesthetic capability in 
reducing pain perception during injections; however, others have concluded that topical 
anesthetics afford little more than placebo levels of effectiveness. 2,4 can be employed as a 
supplementary anesthetic technique to reduce intraoperative pain. 5 
Cryotherapy application is another endorsed strategy for reducing pain perception in patients 
that would be effective, efficient, and cost-effective. 2 
Cryoanesthesia is the application of ice on the anesthetic site to counter nerve conduction of 
pain from the site. Studies have reported that it lowers edema, nerve conduction velocities, 
cellular metabolism, and local blood flow. 2 The application of ice provides physiological and 
psychological benefits to the patients as it may distract them from focusing on their discomfort. 
Their use is much less widespread in dentistry; nevertheless, the use of ice sticks, refrigerants, 
or vapocoolants in the dental operatory to provide pre-injection anesthesia has been described 
in the literature.2 

 
The methods used currently for topical anesthesia before dental injections mainly include 
different types of gel (e.g., lidocaine, prilocaine, or benzocaine 20% (BC)). Unfortunately, 
these gels tend to spread in the mouth due to lack of bio-adhesion, which may result in a 
reduced anesthetic effect 6 , unpleasant taste, and/or discomfort for the patient. 7 Furthermore, 
there is a risk of allergic reactions to several components in the different gels available for 
topical anesthesia8 These factors are important reasons for developing and evaluating other 
substances and techniques for topical anesthesia. Ice was introduced during the nineteenth 
century as a safe method of local anesthesia, 9  and the use of cooling to reduce injection pain 
in the skin is well documented.9,10 
Several explanations for the anesthetic effect of cooling have been proposed.11 The topical cold 
application stimulates myelinated “A” fibers, thereby activating inhibitory pain pathways,12 
perhaps as part of the gate control system at the spinal cord level.11 Furthermore, cooling causes 
cold-induced neuropraxia by decreasing the activation threshold of tissue nociceptors and the 
conduction velocity of nerve signals conveying pain.6,13 Published studies evaluating ice as 
topical anesthesia in dentistry have been reported,14 in addition to the intra-oral use of 
“refrigerant solutions” and “Vapocoolants” (such as 1,1,1,3,3-pentafluoropropane/1,1,1,2-
tetrafluoroethane)14,15 in palatal injections in adults.  Although the effect of the refrigerant agent 
was found to be superior to BC20%,  the use of ice and refigerants as topical anesthesics of the 
oral mucosa is not widely used in dentistry,14 and appears to be non-existent in children.  
Ethyl Chloride (EC) is a topical anesthetic agent used prior to rapid invasive techniques in 
minor surgery and sports medicine. 16 Historically, EC had been used as a general anesthesia 
agent for dental extractions.17 However this practice ceased, with a focus on using it as a topical 
skin anesthesia agent and its uses as a sensibility testing agent18,19  for teeth. When applied by 
aerosol on the skin, its rapid vaporization causes a tissue cooling of up to -20°C, generating an 
insensitivity of the peripheral nerves and, consequently, immediate local anesthesia lasting for 

 
a few minutes. It does not present incompatibilities, interactions, or side effects beyond a local 
and transient hypersensitivity due to the cold.1616 It had been suggested that because EC has a 
rapid effect, it can safely provide cutaneous analgesia in children in circumstances when it is 
impractical to wait for other local anesthetic preparations to take effect.20 This could be 
extrapolated to the oral cavity and dentistry. However, as far as the authors know, although 
there is a registered trial ongoing at the moment 21  comparing EC effect on the oral mucosa in 
comparison to Lidocaine 5%, none have compared EC to BC 20% intraorally in children. 
Therefore this study aims to describe a new method of topical anesthesia of oral mucosa pre-
local anesthesia injection and to compare the perceived pain, and subjective experience of two 
topical anesthetic agents, BC 20% gel and indirect application (using cotton palettes) of Ethyl 
Chloride spray. 
 
3. Aims of the study  
 
To compare the efficacy of 20% Benzocaine (BC) gel and indirect application of Ethyl 
Chloride (EC) spray, in reducing pain perception during local anesthesia infiltration in 
pediatric patients as well as describe a new simple method for topical anesthesia.  
  
Specific objectives 
 
§ To compare the efficacy of BC and EC on buccal infiltration.  
§ To compare the physiological changes observed during the administration of local 
anesthesia with two pre-anesthesia topical application techniques (BC and EC).  
§ To compare the reported and observed pain perception of two topical anesthetic 
techniques (BC & EC) with different age groups and gender. 

 
 
Research question 
§ How effective is the indirect application of EC topical spray anesthesia on pain 
perception during intraoral buccal injection in children in comparsion to BC 20%? 
 
Null Hypothesis: 
§ There is no difference between EC topical anesthesia and BC 20% topical gel on 
the pain perception buccal during infiltration. 
 
4. Materials and Methods 
 
Study Design 
The proposed study is a randomized control trial, single-blinded, following CONSORT Group 
22, and Standard Protocol Items: Recommendations for Interventional Trials reporting 
guidelines23.   
Population: 
All healthy children and adolescents aged 7 to 10 seeking pediatric dental care who meet the 
inclusion criteria and sign the consent form (Appendix II).  
PARTICIPANTS, INTERVENTIONS, AND OUTCOMES 
A. Study Design / Location/ Candidates 
The proposed study is a single-blinded randomized control trial.  The study will investigate the 
pain perception during buccal infiltration using indirect EC spray ( spraying EC 10 cm distance 
of the cotton palette and applied on the oral mucosa for 30 seconds at the site of injection prior 

 
to local anesthesia injection)  topical anesthesia and BC 20% topical gel applied for 30 seconds 
on dried oral mucosa and left for 1 minute using  the end of an applicator stick (among seven 
to 10-year-old school children who attended Pediatric Dentistry Department at Dubai Dental 
Hospital (DDH), Mohammed Bin Rashid University (MBRU)  in Dubai, the United Arab 
Emirates (UAE). 
 
B. Eligibility criteria 
 
Inclusion criteria  
§ Healthy children (ASA I) aged between 7 – 10 years old. 
§ Needing any maxillary buccal infiltration (anterior, middle, posterior) 
§ Had no prior history of local anesthesia. 
§ Frankl behavior III or IV 
§ Not taking any painkillers, or other drugs that would influence with their pain 
perception. 
 
Exclusion Criteria 
§ History of a medically compromised condition and intellectual disability.  
§ Any allergy to local anesthesia. 
§ Active pathology at the site of injection. 
§ Prior history of intra-oral injection.   
§ Frankl behavior I or II. 
§ Children/parents not willing to participate in the study. 
§ Needle phobia.  
§ Patients require treatment under conscious sedation. 
 
C. Sample Size  
Cochrane sample size calculation for detecting a minimum difference of between visual 
analog score for the study and control groups  
𝑛= 2 %
𝑧!"#/% + 𝑧!"&
𝑆𝐸
*
%
 
Where  

 
𝑆𝐸= 𝜇'
𝜎'
 
 
From the study of Lakshimi Lakshmanan and Vignesh Ravindran, the analog score yields the 
following measures for the study and control groups 40.66 ± 14.60 and 61.33 ± 9.73, 
respectively:  
μd = 20.67 and δd = 12.41, the SE = 1.67, and the different scenarios according to power are 
as follows:  
Power 
𝛼 
2(𝑧!"#/% + 𝑧!"&)% 
Sample size 
0.95 
0.01 
31.5 
53 
 
0.05 
26 
43 
0.90 
0.01 
17.1 
29 
 
0.05 
21 
35 
0.80 
0.01 
20.1 
34 
 
0.05 
12.4 
21 
 
With a power of 80% and a significance level of 5%, the minimum sample is 21 children in 
each arm. 
 
 
Fig 1: Study Flow Chart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Block Randomaization  
(Group A) 
 
EC topical application 
for 30 sec 
Administration of the LA by a single blinded 
operator 
Excluded participants 
Fulfilled eligibility criteria 
Initial Assessment 
(Group B) 
 
BC 20% Topical gel 
application for 30 sec and 
left for 1 minute 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
D. Procedure and Indices: 
 
Randomization, Blinding and the procedure with topical anesthesia (EC or BC):  
Pre-local analgesia topical BC or EC technique will be selected randomly and applied per the 
protocol. A single calibrated operator (A.A) using randomly selected sealed envelopes that 
have been previously divided equally according to sample size arms. The selected envelope is 
then opened by the operator, who applies either the EC or BC topical anesthesia technique 
based on the chosen envelop. Followed by maxillary local analgesia buccal infiltration for a 
single tooth by a calibrated operator (A.A). The child is then observed and assessed by the 
blinded primary investigator (N.A) (to the topical anesthesia technique) for pain perception 
during local anesthesia infiltration based on the Sound, Eye, Motor index used in this study. 
The child is then asked to rate the Visual Analog Scale and Facial Pain Scale. Heart rate of the 
patient will be recorded as per below protocol.  
1- Heart rate (HR) 
Physiological changes in HR will be measured in beats per minute (bpm) and registered using 
a pulse oximeter. Each participant's heart rate will be recorded immediately before and after 
the injection using an FDA-approved pulse oximeter (SantaMedical SM-165 Fingertip Pulse 
Oximeter ®, China). The injection site will be dried and isolated using a cotton roll. A small 
Analysis of Pain by a Blinded evaluator 
F.P 
scale 
SEM 
scale 
VAS 
scale 
HR 
changes 
BC ( Benzoczine gel), EC (Ethyl Chloride), HR (Heart rate), SEM ( Sound, Eye, 
Motor ) index, VAS (Visual Analog Scale) and F.P (Face Pain scale). 

 
quantity of the topical anesthesia 20% Benzocaine (Dharma Research, Miami, USA®) 
anesthetic gel will be applied using the end of an applicator stick directly at the site of 
penetration for 30 s and then left for 1 min to ensure effectiveness. All the time periods will be 
calculated using the clock App timer available on an iPhone®. The injection of the anesthetic 
solution is performed according to the standard technique mentioned below. Directly after the 
injection, the pulse rate will be recorded a second time. 
Protocol for injection of local anesthetic solution:  
The injection will be  made with 1.8 ml Lidocaine 2% (DENTSPLY Pharmaceutical, USA®); 
(adrenaline: 1:100.000), delivered in cartridges using a 27—gauge short needle (0.4×25 mm, 
C-K jet). A sterile non-aspirating syringe will be used, as recommended for infiltration 
anesthesia for maxillary teeth. The anesthetic solution will be administered into the buccal 
sulcus of the tooth following a standard technique. The syringe will be held parallel to the long 
axis of the tooth while the tissue is pulled out. Next, the needle will be inserted into the 
mucobuccal fold above the apex of the tooth at a 45° angle with the buccal cortical plate of the 
bone and with the gauge facing the bone. A few drops of the local anesthetic solution will be 
deposited immediately before the needle enters the tissue. After 2 to 3s, the needle will advance 
apically until the bone is contacted without penetrating the periosteum. The rest of the solution 
is then administered slowly over approximately 1 min. The needle is then withdrawn gently 
and slowly. 
2- Sound, Eye, Motor (SEM) Index 

 
 
 
During the insertion of the needle, the operator will evaluate the patient’s behavior for pain 
perception using sound, eye, motor (SEM) scale and visual analog scale (VAS).2  
 
3-  Visual Analog Scale (VAS) 
 
 
1-3 = mild pain 
4-6 = moderate pain 
7-10 = severe pain 
 
 
The VAS scale is a 100-mm long horizontal line labeled “no pain: at one end and “worst pain 
possible” at the other. 2 
Participant’s ratings: 
After each procedure (EC or BC), the participants are asked to evaluate the degree of pain 
(primary outcome) they experienced using the Facial Pain Scale below. 
 
4- Face Pain Scale  
 

 
 
These faces show how much something can hurt. This face (point to leftmost face] shows no 
pain. The faces show more and more pain [point to each from left to the right] up to this one 
[point to rightmost face] - it shows very much pain. Point to the face that shows how much the 
child is hurt. Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so ’‘0' = ‘no pain’ 
and ’‘10' = ‘very much pain. Do not use words like “happy’ and ’‘sad'. This scale is intended 
to measure how children feel inside, not how their face looks. Brief word instructions: Point to 
each face using the words to describe the pain intensity. Ask the children to choose a face that 
best describes their pain and record the appropriate number. 2 
 
E. Piloting and Calibration 
The study design and methodology will be piloted on five patients. In addition, Intra-and-
Inter examiners calibration will be done on recording the indices and topical and local 
analgesia application techniques with a consultant in pediatric dentistry.  
 
F. Data Collection 
 The data will be collected by the principal investigator (N.A), and the data collection sheet 
will record the findings obtained using a Microsoft Excel® standard proforma (Appendix I).  
Each participant will have a specifically coded data collection sheet. Initially, the data 
collection sheet will be identifiable by the child’s name.  Once the data collection sheet and the 
consent (Appendix II) are checked for completeness, the data collection sheets will be coded, 
and the patient’s identifications will be covered for the patient’s confidentiality.  

 
G. Study Timeline  
October 2022 
Writing the Protocol 
April 2023 
IRB Approval, Study Registration, and Pilot Study 
May – August 2023 
Data Collection and randomization 
September 2023  
Data analysis and results  
October 2023 
Discussion and Conclusion  
 
 
H. Statistical Analysis 
Data will be entered into a computer using SPSS® for windows version 28.0 (SPSS Inc., 
Chicago, IL). Descriptive statistics will be used to describe categorical and continuous 
variables by proportion and measure of tendency, and measure of dispersion, respectively. The 
continuous measurements: score of analog and other variables (H) will be tested for normality 
using Shapiro Wilk. Comparisons between two arms will be administered on the function of 
the normality test using Parametric (T-test, chi-square) or non-parametric (Mann-Whitney test 
or exact fisher test). A P-value of less than 0.05 will be considered significant in all statistical 
analyses. 
 
I. Ethical considerations 
 
All patients fulfilling the basic inclusion criteria will be eligible for participation. The Principal 
Investigator will be responsible for identifying those prospective patients who do not fulfill the 
eligibility criteria so that they are not approached. Eligible patients will be approached in the 
clinic, invited to participate and subsequently examined by the clinical investigator to verify 
eligibility. The purpose of the study will be explained to parents/guardians and the consent 

 
form will be provided to those who fulfill the study and assent/agree to participate. Children 
and parents/guardians will be given time to carefully read the consent form. It will ensure that 
they fully understand the consent form, and any questions will be answered. The participants 
will be expected to assent, i.e., affirmatively agree, to participate in the research project, and 
their parents/guardians will provide consent. The researcher obtaining informed consent will 
not be providing the treatment in order to avoid any appearance of undue coercion. 
 
 
 
 
 
 

 
References: 
1. 
Dasarraju RK, SVSG N. Comparative efficacy of three topical anesthetics on 7-11-
year-old children: a randomized clinical study. J Dent Anesth Pain Med. 
2020;20(1):29. doi:10.17245/jdapm.2020.20.1.29 
2. 
Lakshmanan L, Ravindran V. Efficacy of cryotherapy application on the pain 
perceptioduring intraoral injection: A randomized controlled trial. Int J Clin Pediatr 
Dent. 2021;14(5):616-620. doi:10.5005/jp-journals-10005-2032 
3. 
Reducing Children’s Injection Pain: Lidocaine Patches versus Topical Benzocaine 
Gel. 
4. 
Gill CJ, Orr DL. A double-blind crossover comparison of topical anesthetics. J Am 
Dent Assoc. 1979;98(2):213-214. doi:10.14219/jada.archive.1979.0476 
5. 
Lakshmanan L, Ravindran V. Efficacy of cryotherapy application on the pain 
perceptioduring intraoral injection: A randomized controlled trial. Int J Clin Pediatr 
Dent. 2021;14(5):616-620. doi:10.5005/jp-journals-10005-2032 
6. 
Hindocha N, Manhem F, Bäckryd E, Bågesund M. Ice versus lidocaine 5% gel for 
topical anaesthesia of oral mucosa-a randomized cross-over study. BMC Anesthesiol. 
2019;19(1). doi:10.1186/s12871-019-0902-8 
7. 
Hersh E v., Houpt MI, Cooper SA, Feldman RS, Wolff MS, Levin LM. Analgesic 
efficacy and safety of an: Intraoral lidocaine patch. Journal of the American Dental 
Association. 1996;127(11):1626-1634. doi:10.14219/jada.archive.1996.0098 
8. 
Amado A, Sood A, Taylor JS. Contact allergy to lidocaine: A report of sixteen cases. 
Dermatitis. 2007;18(4):215-220. doi:10.2310/6620.2007.06059 
9. 
Silver K, Silver J. The place of James Arnott (1797-1883) in the development of local 
anaesthesia in dentistry. Br Dent J. 2016;220(5):249-252. doi:10.1038/sj.bdj.2016.179 
10. 
Davoudi A, Rismanchian M, Akhavan A, et al. A brief review on the efficacy of 
different possible and nonpharmacological techniques in eliminating discomfort of 
local anesthesia injection during dental procedures. Anesth Essays Res. 2016;10(1):13. 
doi:10.4103/0259-1162.167846 
11. 
Ernst E, Fialka V. Ice Freezes Pain? A Review of the Clinical Effectiveness of 
Analgesic Co1. Vol 9.; 1994. 
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Gupta M, Gugnani N, Lathwal G, Pandit IK. Efficacy of Different Precooling Agents 
and Topical Anesthetics on the Pain Perception during Intraoral Injection: A 
Comparative Clinical Study. Int J Clin Pediatr Dent. 2015;8(2):119-122. 
doi:10.5005/jp-journals-10005-1296 
13. 
Malanga GA, Yan N, Stark J. Mechanisms and efficacy of heat and cold therapies for 
musculoskeletal injury. Postgrad Med. 2015;127(1):57-65. 
doi:10.1080/00325481.2015.992719 
14. 
Kosaraju A, Vandewalle KS. A comparison of a refrigerant and a topical anesthetic gel 
as preinjection anesthetics A clinical evaluation. Journal of the American Dental 
Association. 2009;140(1):68-72. doi:10.14219/jada.archive.2009.0020 
15. 
Dimarco AC, O’ A, Wetmore K. Clinical Comparison: Fast-Acting and Traditional 
Topical Dental Anesthetic. 
16. 
Ballesteros-Peña S, Fernández-Aedo I, Vallejo-De La Hoz G. Ethyl Chloride Aerosol 
Spray Efficacy for Local Anaesthesia before Arterial Puncture: Randomized Placebo-
Controlled Trial. Vol 29.; 2017. 
17. 
DENTAL ANAESTHESIA IN CHILDREN THE BRITIStH 433 MEDICAL JOURNAL.; 
1940. 

 
18. 
Hori A, Poureslami HR, Parirokh M, Mirzazadeh A, Abbott P. The ability of pulp 
sensibility tests to evaluate the pulp status in primary teeth. Int J Paediatr Dent. 
2011;21(6):441-445. doi:10.1111/j.1365-263X.2011.01147.x 
19. 
Asfour MAM, Millar BJ, Smith PB. An assessment of the reliability of pulp testing 
deciduous teeth. Int J Paediatr Dent. 1996;6(3):163-166. doi:10.1111/j.1365-
263x.1996.tb00235.x 
20. 
Russell SCS, Doyle E. RISK-BENEFIT ASSESSMENT A Risk-Benefit Assessment of 
Topical Percutaneous Local Anaesthetics in Children. Vol 16.; 1997. 
21. 
Hira Abbasi AI of DM. https://clinicaltrials.gov/ct2/show/NCT05306470. 
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Methods: Participants, Interventions, and Outcomes. 
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Chan AW, et al. “SPIRIT 2013 Statement: defining standard protocol items for clinical 
trials.” Rev Panam Salud Publica . 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
MOHAMMED BIN RASHID UNIVERSITY OF 
MEDICINE AND HEALTH SCIENCES  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  

 
Appendix I  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Appendix I I 
 
Consent Form 
Title of the study: Efficacy of Ethyl chloride topical analgesia application on the pain 
perception during intra-oral injections incomparison to Benzocaine 20% – a single-blinded 
randomized controlled trial. 
Principal Investigator: Dr. Nagah Abdelrahman, Department of Paediatric Dentistry, 
Hamdan Bin Mohammed College of Dental Medicine, Building 34, Dubai Healthcare City, 
Dubai, UAE. Telephone: (055) 122-5599.  
Please take your time to review this information form, and feel free to consult with or discuss 
this study with your dentist, colleagues, family, friends, and/or physician before deciding 
whether or not to participate. If you have any questions regarding the study or any related issues 
we encourage you to ask the principal investigator, as listed above. This consent form may 
contain words that you do not understand. Please ask the research staff to explain any words 
or information you do not clearly understand.  
Purpose of the study  
This study is being conducted by the Hamdan Bin Mohammed College of Dental 
Medicine, Department of Pediatric Dentistry; to compare the efficacy of 20% Benzocaine 
(BC) gel and indirect application of Ethyl Chloride (EC) on cotton palette, applied on the 
oral mucosa prior to needle stick and injection of local anaesthesia at reducing pain 
perception during LA infiltration in pediatric patients as well as describe a new simple 
method for topical anesthesia.  
Study procedures  
If you choose to take part in this study, the following procedures will happen: The Benzocaine 
gel (20%) or indirect Ethyl Chloride spray will be applied on the mucosa prior the injection 
used in order to start the treatment.  

 
You may stop participating in this study at any time. However, if you decide to stop 
participating, we encourage you to talk to the research staff first.  
Risks and discomforts  
There are no recognized risks or discomforts that may be caused to your child by participation 
in the study.  
Benefits  
There may or may not be a direct benefit to your child from participating in this study. We 
hope the information we collect will help us and parents to better recognize the best type of 
topical anesthesia for the children. 
Cost/Payment  
There is no cost to you for participating in the study and you will receive no payment or 
reimbursement for any expenses related to taking part in this study.  
Alternatives, you should feel no obligation to participate in the study.  
Confidentiality  
All information obtained from this study is confidential and will remain so. Information 
gathered in this study may be published or presented in public forums; however, your name 
and other identifying information will not be used or revealed. In any published data, your 
identity (and your child’s) will be protected and treated as confidential according to the 
Personal Health Information Act of UAE. To protect your identity, every participant will be 
given a Study Number instead of their name in all documents related to the study. All 
information obtained from this study will be used strictly for research purposes only. If the 
study information is used in any subsequent investigation, your consent will be taken.  
Hamdan Bin Mohammed College of Dental Medicine Research Ethics Committee may review 
study records for purposes of quality assurance only. Despite efforts to keep your personal 
information confidential, absolute confidentiality cannot be guaranteed. Your personal 
information may be disclosed if required by law.  
All records relating to this study will be kept in a secure, locked area and only those persons 
identified will have access to these records. If any of your child’s medical/research records 
need to be copied to any of the above, his/her name and all identifying information will be 
removed. No information revealing any personal information such as your/your child name, 
address or telephone number will leave the HBMCDM.  

 
Voluntary participation / Withdrawal from the study  
Your decision to allow your child to participate in the study is voluntary. You may refuse to 
give consent for child to participate in the study or withdraw from it at any point in time. If the 
research staff feels that it is in your child best interest to withdraw her/him from the study, they 
will remove you without your consent.  
We will tell you about any new information that may affect your child health, welfare, or 
willingness to stay in this study.  
Questions  
Please feel free to ask questions regarding the study or anything related to it that requires further 
clarification.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Statement of Consent 
 
I have read this consent form. I have had the opportunity to discuss this study with Dr. Nagah 
Abdelrahman and/or his research staff. I have had my questions answered in a language I 
understand. All risks, benefits, costs, and alternatives regarding this study have been 
thoroughly explained to me. I believe that I have not been unduly influenced by any research 
team member to participate in the study by any statements or implied statements. Any 
relationship I or my child may have with the research team has not affected my decision to 
participate. I understand I will be given a copy of this consent form after signing it. I understand 
my and my child’s participation in the study is voluntary and I may choose to withdraw my 
child from it at any point in time. I freely agree to participate in this research study and I give 
consent for my child to participate in the research study as well.  
I understand that any information regarding my child’s identity will be kept confidential, but 
that confidentiality cannot be guaranteed. I authorize the inspection of any of my records 
related to this study by the Hamdan Bin Mohammed College of Dental Medicine Research 
Ethics Board for quality assurance purposes.  
By signing this consent form I have not waived any of the legal rights that I or my child have 
as a participant in a research study.  
Parent/legal guardian’s signature: ___________________ 
Date: ____________________ (day/month/year) 
Parent/legal guardian’s printed name: _______________________________  
I, the undersigned, attest that the information in the participant Information and Consent Form 
was accurately explained to, and apparently understood by, the participant or the participant’s 
legally acceptable representative and that the consent to participate in this study was freely 
given by the participant or the participant’s legally acceptable representative.  
Witness signature: ____________________________ 
Date: ___________________ (day/month/year) 
Witness printed name: ______________________________________