Condition category
Not Applicable
Date applied
21/10/2020
Date assigned
22/10/2020
Last edited
06/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://zna.be

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

Editorial Notes

06/11/2020: Uploaded protocol (not peer reviewed) Version 1.0, 26 May 2020. 22/10/2020: Trial’s existence confirmed by Commissie voor Medische Ethiek ZNA