Risk Factors to Develop Chronic Postsurgical Pediatric Pain: An Observational Study
Conditions: Chronic Postoperative Pain, Pediatric ALL
Sponsor: Guillermo Ceniza Bordallo

Chronic postsurgical pediatric pain. Observational Study. Guillermo Ceniza-Bordallo et 
al. 15 December 2020. University Complutense of Madrid.  
 
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TITLE: RISK FACTORS TO DEVELOP CHRONIC POSTSURGICAL PEDIATRIC PAIN 
 
INVESTIGATOR PRINCIPAL: GUILLERMO CENIZA-BORDALLO 
 
PROJECT ENTITIES:  COMPLUTENSE UNIVERSITY OF MADRID & 12 
OCTUBRE PEDIATRIC HOSPITAL.  
 
NUMBER OF IDENTIFIACTION: 26/618 
 
DATE:  15TH December 2020.  
 
 
 
 
 
 
 
 
CHRONIC POSTSURGICAL PEDIATRIC PAIN. 

Chronic postsurgical pediatric pain. Observational Study. Guillermo Ceniza-Bordallo et 
al. 15 December 2020. University Complutense of Madrid.  
 
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STUDY PROTOCOL 
Type of Study: Observational longitudinal prospective. The study has approved 
by etic comity of clinical research of Hospital 12 de octubre de madrid.  
Target population: Pediatric population undergoing surgery intervention in 12 
de octubre hospital.  
Sample: A convenience sampling will be carried out among the patients 
undergoing surgical intervention according eligibility criteria. 
• 
Inclusion criteria: Children with age from 4 years to 18 years. Undergoing 
surgery for any surgical specialty. ASA Status (American Society of 
Anesthesiologist) from I to III. 
• 
Exclusion Criteria: Children who do not understated and speak Spanish 
correctly. Children with verbal communication problems. 
• 
Stratification of the sample:  The sample will be divided into 2 sample 
groups: a) children into 4 to 8 years, and b) children into 8 to 18 years.  
• 
Sample size: To assess the degree of association between the different 
clinical variables and the development of chronic postsurgical pain in the 
pediatric population, the calculation of the sample size was based on 
previous literature that proposes 20 cases per variable in order to estimate 
a prediction model in a relatively stable manner. Therefore, taking into 
account that a total of 13 predictor variables were used (anxiety, 
catastrophism, fear of pain, fear of movement, pain interference, disability, 
limitation of activities, prediction of chronic pain in children and 

Chronic postsurgical pediatric pain. Observational Study. Guillermo Ceniza-Bordallo et 
al. 15 December 2020. University Complutense of Madrid.  
 
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catastrophism, anxiety, fear of pain, fear of movement of parents / 
guardians / companions), it was considered necessary to include at least 
260 children undergoing surgery to meet the objective of this study 
 
 
 Study design. 
• 
On the day of admission to the pediatric surgery service of the hospital, 
the potential participant and parents of the study in progress will be 
informed. First, patients and parents will be informed about the possibility 
of voluntary participation in the study. Next, the objective, process and 
potential benefits of this will be reported. The consent of the legal 
guardians will then be requested. They will be asked to fill in the 
information of the demographic and clinical variables, answering the self-
assessment instruments (the data collection will have an estimated time 
of 30 'per subject), both children and parents / companions. After the 
surgical intervention and within a period comprised in the first 5 days, an 
evaluation of the dependent variables (intensity, location and distribution 
of pain) will be carried out in both children and parents. They should fill in 
the self-assessment instruments in the same way as in the pre-surgery 
session (this will take approximately 10 minutes). 
• 
At 10 days, 3 months, 6 months and 12 months after the intervention, 
will contact the patients and relatives by telephone, and they will be asked 
to reply again to the evaluation of all the variables. The evaluation will be 
carried out by telephone interview. 
• 
The information sheet, the informed consent, and the evaluation 
instruments will be collected by a researcher, stored and guarded in the 
Department of Radiology, Rehabilitation and Physiotherapy of the 
Complutense University of Madrid. Thus, complying with the provisions of 
Organic Law 3/2018, of December 5, on the Protection of Personal Data 
and guarantee of digital rights. 
 

Chronic postsurgical pediatric pain. Observational Study. Guillermo Ceniza-Bordallo et 
al. 15 December 2020. University Complutense of Madrid.  
 
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Ethical Aspects 
The study has the approval of the research commission of the Faculty of Nursing, 
Physiotherapy and Podiatry of the Complutense University of Madrid. Also, with 
the favorable opinion of the research commission of the Hospital 12 de Octubre 
Research Institute (i + 12). Lastly, it will be evaluated by the Ethics Committee of 
the research institute Hospital Universitario 12 de Octubre de Madrid (1 + 12). 
The study will comply with all the ethical principles of the Declaration of Helsinki. 
All participants will participate in the study on a voluntary basis. They will be 
informed of the objective of the study, the procedure, and the process of carrying 
it out. In addition, the informed consent of each participant and their guardians 
will be required, which may be revoked at any time. In addition, they are within 
their right to know the results of the investigation once it has been completed. 
The clinical and personal information will be totally confidential where the 
researchers will comply with the confidentiality commitments of the hospital 
center and the Faculty of Nursing, Physiotherapy and Podiatry. The treatment, 
communication and transfer of personal data of all participating subjects will 
comply with the provisions of the General Regulations for the Protection of 
Personal Data (Regulation 2016/679 of the European Parliament) and Organic 
Law 3 / 2018, of December 5, Protection of Personal Data and guarantee of digital 
rights. 
The study does not hinder, modify, or interfere with routine clinical practice. Nor 
does it modify the service care protocols. The time of data collection is estimated 
at 30`. This time is not excessive for patients and their families and can provide 

Chronic postsurgical pediatric pain. Observational Study. Guillermo Ceniza-Bordallo et 
al. 15 December 2020. University Complutense of Madrid.  
 
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very relevant research and clinical information in order to understand the 
mechanisms of chronic pain in the pediatric population. This could save on 
medical care after the intervention, shortening the periods of hospitalization and 
readmission. 
Therefore, it is considered that carrying out the study complies with the ethical 
and research standards and that the benefits in knowledge in the field that can 
be derived from it could significantly improve the healthcare activity, not assuming 
the realization of this, a serious damage to patients, families or professionals.