Plain English Summary
Background and study aims.
More and more operations in children take place in an outpatient setting (no overnight stay in hospital). Consequently, parents at home play an increasingly important role in the postoperative care of their child.
An essential part of this care is to recognize and treat pain, which is not always evident in children because they also show certain behavioral changes after an operation. Queen Paola Children’s Hospital is currently conducting research into these behavioral changes in children after an operation and pain measurements by parents.
Who can participate?
Children between 2 and 12 years old who will undergo an outpatient operation.
What does the study involve?
Prior to the operation parents fill in a questionnaire concerning their child’s behavior.
Once back home after the operation the parent will keep a diary for five days, in which the behavioral changes of the child are scored twice a day (in the morning after breakfast and in the evening after supper).
If the child is older than 6, they will be provided with a diary to indicate a pain score by means of a face scale twice a day done at the same time as the parent diary.
What are the possible benefits and risks of participating?
None
Where is the study run from?
ZNA Middelheim - Queen Paola Children’s hospital (Belgium)
When is the study starting and how long is it expected to run for?
December 2019 to December 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Johan Berghmans, johan.berghmans@zna.be
Trial website
Contact information
Type
Scientific
Primary contact
Dr Johan Berghmans
ORCID ID
http://orcid.org/0000-0002-3835-562X
Contact details
Wijerveldstraat 69
Hasselt
3500
Belgium
+32 (0)478496755
johan.berghmans@zna.be
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
E.C. 5394
Study information
Scientific title
The Dutch version of the Parents’ Postoperative Pain Measure (PPPM) – validity and reliability in the assessment of postoperative pain among children aged between 2 and 12 years
Acronym
PPPM-D-form
Study hypothesis
To establish the reliability, validity, and sensitivity to change overtime (longitudinal sensitivity) of the Dutch version of the Parents’ Postoperative Pain Measure (PPPM-D) in the assessment of postoperative pain among children aged between 2 and 12 years.
Ethics approval
Approved 08/07/2020, Commissie voor Medische Ethiek ZNA, Institutional Review Board (ZNA/OCMW Antwerpen, Lindendreef 1, 2020 Antwerpen, Belgium; +32(0)32803429; ), ref: 009;OG 031; E.C. 5394
Study design
Single-centre prospective observational study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Assessment of postoperative pain
Intervention
A formal forward-back-forward translation procedure to translate the PPPM into Dutch (PPPM-D) will be carried out. Furthermore an expert panel of two psychologists and two anesthesiologists will evaluate the translation.
This prospective observational study aims to include 120 children stratified according to:
1. Child’s age - age between 2-5 and between 6- 12 years of age (dichotomy based on the child’s ability to self-report of pain intensity by using the Faces Pain Scale Revised – FPS-R)
2. Different kinds of surgery (general, orthopedic, urologic, maxillofacial and otolaryngologic) related to the expected level of postoperative pain intensity levels (mild, moderate, severe).
After receiving precise instructions one accompanying parent will complete the PPPM-D at the day of surgery (before the intervention) and directly after surgery in the evening and this parent will later rate the child’s pain twice a day (morning-evening) during the first 5 postoperative days. In parallel with the PPPM assessments, parents will also use a Numerical Rating Scale (NRS) to assess the pain of their child. Also, children between 6 and 12 years will rate their pain intensity twice a day during 5 days postoperative by using the Faces Pain Scale Revised (FPS-R).
Intervention type
Other
Phase
Drug names
Primary outcome measure
Pain measured using the Dutch version of Parents’ Postoperative Pain Measure (PPPM-D) two times each day by parents (after breakfast and in the evening after dinner) during five consecutive days. Parents will also fill in the PPPM-D on the day of surgery before the intervention as basic assessment
Secondary outcome measures
1. Pain measured using a Numerical Rating Scale (NRS-11) two times each day by parents (after breakfast and in the evening after dinner) during five consecutive days. Parents will also fill in the NRS on the day of surgery before the intervention as basic assessment
2. Pain measured using the Faces Pain Scale-Revised (FPS-R) two times each day during 5 postoperative days (self report by the children)
Overall trial start date
01/12/2019
Overall trial end date
01/11/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children 2 – 12 years old
2. Information and consent forms for parents and an assent form explained to the child
3. Undergoing one of the following surgical procedures: inguinal hernia repair, myringotomy, adenoidectomy, gastroscopy, dental surgery, orchidopexy, strabismus, circumcision, adenotonsillectomy, orthopedic osteosyntheses
4. One accompanying parent present at induction
5. Parents who speak and understand Dutch
6. No premedication
Participant type
Mixed
Age group
Child
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Known mental/cognitive retardation
2. American Society Anesthesiologists ASA physical status >II
Recruitment start date
01/11/2020
Recruitment end date
01/12/2021
Locations
Countries of recruitment
Belgium
Trial participating centre
ZNA Middelheim - Queen Paola Children's Hospital
Lindendreef 1
Antwerpen
2020
Belgium
Sponsor information
Organisation
ZNA Middelheim Hospital
Sponsor details
Lindendreef 1
Antwerpen
2020
Belgium
+32 (0)32803993
stefaan.goossens@zna.be
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
30/12/2021
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN12813822_PROTOCOL_v1.0_26May2020.pdf uploaded 06/11/2020