Comparison of Pain Scores by Using Audiovisual Distraction Aids in Post Operative Paediatric Patients.
Phase: NA
Conditions: Postoperative Pain, Acute
Sponsor: Aga Khan University

 
 
 
 
 
TITLE: 
Distraction techniques for post-operative pediatric patients in post anaesthesia 
care unit (PACU); a randomized control trial 
 
ERC number: 2020-2172-14474 
 
Dated: 06-10-2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
Distraction techniques for post-operative pediatric patients in post anaesthesia care unit (PACU); a 
randomized control trial 
 
INTRODUCTION: 
Pediatric pain is complex involving physiological, behavioral and developmental factors.  In spite of different 
assessment tools, the pediatric pain is mostly underestimated and under treated. Many at times physicians do 
not want to treat pain because of fear of side effects or sedations which hinders discharge from Post 
Anaesthesia Care Unit (PACU). Another problem in our part of the world is availability of the medications 
like short acting narcotics and lack of regional anaesthesia practices. In addition to the standard 
pharmacological treatment non-pharmacological therapies like distraction can be used to treat the affective, 
cognitive, behavioral and socio-cultural dimensions of pain.1 Distraction has been used effectively in the 
emergency department to guide children’s attention away from the painful stimuli and reduce pain2.  But use 
of this method in the postoperative anesthesia care unit is still limited. 
The aim of this study is to compare the distraction method with the conventional pharmacological method in 
pediatric postoperative pain management, as this method is simple, economical and is devoid of any adverse 
effects. 
 
OBJECTIVE:  
The aim of this study is to compare the post operative analgesia between two groups (Group C and Group 
CD) receiving conventional analgesia with or without distraction technique. Group C will only receive 
conventional analgesia while group CD will receive conventional analgesia as well as distraction technique. 
Operational definition:  
• 
Distraction technique is a non-pharmacological method of pain relief for post-operative paediatric 
patients in post anesthesia care unit. (games on tablets, listening poems, watching cartoons) 
• 
Conventional analgesia is the standardize rescue analgesia of intravenous administration of 
analgesics in post anesthesia care unit (PACU) prescribed. The analgesia will include I/V Tramadol 
0.5 to 1mg/kg and Paracetamol 10mg/kg).  
 
Primary outcome: 
1. Pain scores using Wong-Baker FACES® pain rating scale 3 
2. Use of rescue analgesia 
Secondary outcome: Parent’s satisfaction. 

MATERIALS & METHODS: 
SETTING: This study will be conducted at post anaesthesia care unit of Department of Anesthesiology, Aga 
Khan University Hospital Karachi. 
DURATION OF STUDY: Six to twelve months after approval of synopsis. 
STUDY DESIGN: Randomized control trial 
SAMPLING TECHNIQUE: Consecutive sampling methods 
 
SAMPLE SELECTION:  
Inclusion Criteria: 
➢ All elective cases on paediatric list (orthopaedics, plastic surgery, paediatrics surgery) 
➢ ASA I and II 
➢ Children 3 to 7 years of age. 
Exclusion Criteria: 
➢ Parent’s refusal for participation. 
➢ CP child/ neurologically challenged pediatric patients 
➢ Paediatric patients undergoing head, neck, ENT and Neurosurgery. 
➢ Emergency surgery 
➢ Language barrier ( failure to understand Urdu and English ) 
➢ Difficult airway. 
Sample Size: Sample size calculation is performed by using software PASS version 11.04 and based on 
previous study 4 .Post-operative mean pain score was reported 3.95(SD=1) in conventional groups. Assuming 
25% difference in reduction and aiming for a power 80% and a risk of 0.05 for a type-I error, 14 patients will 
be required for each group. We will include 20 patients per group to anticipate a 30% dropout rate.  
 
Ethics: Written informed consent will be taken from patient’s parents/guardian participating in the study in 
ward. A copy of the informed consent will be given to the parents/ guardian. The confidentiality of the patient 
and data will be maintained by assigning a number for each patient data, electronic data will be password 
protected and data on hard copies will be kept in a lock and key. 
Data Collection:  The study will be conducted after approval from Hospital Ethical Review committee of 
Aga Khan University Hospital, Karachi. All pediatric patients fulfilling the inclusion criteria will be enrolled 
in the study. The purpose along with procedure of the study will be explained to the parents/guardian and 
informed consent will be taken in the ward.  The information and the demographics of the patients will be 
entered in the proforma attached as annexure. Data will be collected in the pre designed form. For the purpose 
of data collection the form is divided into two sections: 
SECTION I: - This section will be filled by the primary investigator in operation room. 
SECTION II: - This section will be completed by the data collector in PACU. 

Randomization: Patients will be divided into two equal groups (group C) and (group CD) by computer 
generated random number and the information will be provided to the investigator in the form of sealed 
envelopes which will not be opened until patient consent is obtained. 
Procedure: When the patient received in PACU, the data collector will be informed about the 
allocated group (C or CD). Patients in group C will receive their routine rescue analgesics. While patients 
in group CD will be engaged in distraction methods once the child is awake and his/her response will be 
noted in form II at given intervals. Heart Rate (H/R), Blood pressure (BP), oxygen saturation and respiratory 
rate (R/R) will be noted from the monitors. The pain scale will be noted with the help of given Wong Baker 
faces pain scale on proforma. Routine rescue analgesia will be used if patient still experiences pain.  
Distraction Method: These children will be given tablets/smart phone to choose one of the following 
options: 
• 
To play games.  
• 
To listen poems. 
• 
To watch cartoons. 
Data Handling and Record Keeping: It will be the responsibility of primary investigator with 
assistance of data collector. Study monitoring regarding protocol compliance will be done by the 
primary investigator. A copy of the consent form taken will be attached with proforma. The 
confidentiality of the patient and data will be maintained by assigning a number for each patient 
data. The electronic data will be password protected and hard copies will be kept in research cell. 
At the completion of the study, results will be shared with the parents upon their request. Public 
disclosure includes publication of an abstract or full paper in a scientific journal and presentation at a 
scientific meeting. 
Data Analysis:  Data will be analyzed by Statistical packages for social science version 19 (SPSS 
Inc., Chicago, IL).  Endpoint of the study will be patient’s sign out from recovery room. Frequency, 
percentage, mean and standard deviation will be reported for different variables.  
 
References: 
1. Yavuz, M (2006). Ağrıda Kullanılan Nonfarmakolojik Yöntemler, In: Ağrı Doğası ve Kontrolü, 1st 
edition, F.E. Aslan (Editor), Vol.42, pp.135-147. Avrupa Tıp Kitapçılık Ltd. Şti. Bilim Yayınları, 
ISBN: 975-6257-17-2 
2. Vessey JA, Carlson KL, McGill J. Use of distraction with children during an acute pain experience.  
Nursing Research. 1994; 43(6):369–372. [PubMed] 
3. Whaley LF, Wong DL. Nursing care of infants and children, 3rd ed. St. Louise: Mosby; 1987  
4. He H.-G., Jahja R., Lee T.-L., Ang E.N.K, Sinnappan R, Vehvilainen H. -T. -L, Vehvila Inenjulkunen 
K. & Chan M.F. (2010) Nurses’ use of non-pharmacological methods in children’s postoperative pain 
management: educational intervention study. Journal of Advanced Nursing 2010; 66(11), 2398–
2409.doi: 10.1111/j.1365-2648.