The effect of pre-emptive pain relief to prevent postoperative pain in children
| ISRCTN | ISRCTN77862744 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77862744 |
- Submission date
- 22/04/2021
- Registration date
- 26/04/2021
- Last edited
- 21/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study will investigate a method that aims to reduce the intensity of pain in children undergoing Ear, Nose, and Throat (ENT) surgical procedures of removal of the palatine tonsils (tonsillectomy) and adenoid (adenotomy) at the University Hospital in Wroclaw. Pain caused by surgery is the main reason for a child's discomfort period following the surgery. Pre-emptive pain relief is a procedure that is initiated before the onset of the pain stimulus and leads to blocking the pain signal, coming from the surgical wound.
The aim of this study is to evaluate how effective pre-emptive pain relief is in preventing postoperative pain, after ENT surgical procedures in children.
Who can participate?
Healthy children between the ages of 3 and 17 years, who are qualified for surgical treatment in an ENT clinic
What does the study involve?
Participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin). The participants in the first group will be given a pain relief drug (paracetamol) before surgery, in addition to the standard preparation for surgery. The dose of the drug will be adjusted according to the child's weight. The participants in the second group will be given an identical looking treatment with no active medicine before surgery, in addition to the standard preparation for surgery. After surgery participant pain levels will be assessed.
What are the possible benefits and risks of participating?
Paracetamol is a drug that has long been widely used for the treatment of pain in home and hospital settings. The device used to measure pain via skin conductance is noninvasive and painless. The use of pre-emptive analgesia will allow to individually adjust pain therapy to the child's needs. The results of the study will answer the question of whether this method has an effect on the reduction of postoperative pain in children. It is hoped that effectively treated pain will contribute to an increase in comfort for the child hospitalized at the department and a reduction in the length of hospitalization.
Where is the study run from?
Wroclaw Medical University (Poland)
When is the study starting and how long is it expected to run for?
From May 2018 to March 2022
Who is funding the study?
Investigator initiated and funded study
Who is the main contact?
Dr Jakub Zielinski
zielinski.kuba@gmail.com
Contact information
Scientific
Borowska 213
Wrocław
50-556
Poland
 ORCID ID |
0000-0003-1747-2250 |
|---|---|
| Phone | +48717343700 |
| zielinski.kuba@gmail.com |
Public
Borowska 213
Wrocław
50-556
Poland
| Phone | +48717343700 |
|---|---|
| zielinski.kuba@gmail.com |
Study information
| Study design | Single-center interventional double-blinded randomized controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effect of Pre-Emptive Analgesia on the Postoperative pain IN pediatric otolaryngology: a randomized, controlled trial |
| Study acronym | P-EAPIN |
| Study objectives | The administration of pre-emptive analgesia reduces the severity of postoperative pain in children |
| Ethics approval(s) | Approved 16/08/2018, Ethical Committee of the Medical University of Wrocław (Pasteura 1, 50-367 Wrocław, Poland; +48717841014; bioetyka@umed.wroc.pl), ref: KB–459/2018 |
| Health condition(s) or problem(s) studied | Postoperative pain in children |
| Intervention | The study will randomly allocate a patient to an intervention or control group, using permuted block randomization. The intervention group will receive pre-emptive analgesic paracetamol orally (15 mg/kg) and the control group will receive a placebo in addition to midazolam (0.5 mg/kg) as premedication. All children are administered sevoflurane gas, intravenous propofol (between 2 and 4 mg/kg), and fentanyl (2 mcg/kg). During the surgery, all patients receive intravenous dexamethasone (0.2 mg/kg) and nalbuphine (0.2 mg/kg) as standard perioperative analgesia. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | paracetamol, midazolam, sevoflurane gas, propofol, fentanyl, dexamethasone, nalbuphine |
| Primary outcome measure | Postoperative pain measured using the Visual Analogue Scale (VAS), the Wong–Baker Faces Pain Rating Scale, and the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at 1, 2, 4, and 6 h after surgery |
| Secondary outcome measures | Current secondary outcome measures as of 21/06/2022: There are no secondary outcome measures Previous secondary outcome measures: Discomfort with self-adhesive electrodes or cannulation after surgery measured by asking to locate the site of pain in postoperative assessment at 1, 2, 4, and 6 h after surgery |
| Overall study start date | 19/05/2018 |
| Completion date | 01/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 55 |
| Total final enrolment | 51 |
| Key inclusion criteria | 1. Aged between 3 and 17 years 2. Otolaryngological procedure needed 3. Written informed consent to participate in the study from parents (or legal guardians) |
| Key exclusion criteria | 1. Intellectual disability 2. Major coexisting diseases 3. Allergy to paracetamol, dexamethasone, or nalbuphine 4. Pain prior to surgery |
| Date of first enrolment | 19/07/2019 |
| Date of final enrolment | 01/03/2022 |
Locations
Countries of recruitment
- Poland
Study participating centre
Head and Neck Surgery
Borowska 213
Wrocław
50-556
Poland
Sponsor information
University/education
Pasteura 1
Wrocław
50-367
Poland
| Phone | +48717841725 |
|---|---|
| rektor@umed.wroc.pl | |
| Website | http://www.en.umed.wroc.pl/contact/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Jakub Zieliński (zielinski.kuba@gmail.com). Anonymized data available will be available from January 2022, with no time restrictions, and will be shared with healthcare professionals, for research only. Consent from participants was obtained with no ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/05/2022 | 21/06/2022 | Yes | No |
Editorial Notes
21/06/2022: The following changes were made to the trial record:
1. The secondary outcome measures were changed.
2. The target number of participants was changed from 40 to 55.
3. The total final enrolment was changed from 35 to 51.
4. Publication reference added.
15/02/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 27/01/2021 to 01/03/2022.
2. The overall end date was changed from 27/01/2021 to 01/03/2022.
3. The intention to publish date was changed from 01/07/2021 to 01/06/2022.
4. The plain English summary was updated to reflect these changes.
26/04/2021: Trial’s existence confirmed by the Ethical Committee of the Medical University of Wrocław.
