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Analgesic Effect of Laser Therapy in Children

Primary Purpose

Pain, Postoperative

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Laser therapy
Sponsored by
IRCCS Burlo Garofolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Pain, Tonsillectomy, Laser Therapy, Photo-biomodulation

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Tonsillectomy or adenotonsillectomy due to apneic chronic snoring and/or obstructive sleep apnea and/or recurrent tonsillitis

Exclusion Criteria:

  1. American Society of Anesthesiologists (ASA) Score > 2
  2. Neuropsychiatric co-morbidity
  3. Pro-hemorrhage coagulation disorders

Sites / Locations

  • Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laser

Standard care

Arm Description

Laser light will be applied to the surgery site after tonsils excision.

Outcomes

Primary Outcome Measures

Reduction in pain score, age 3-7 years
The score is evaluated using the Wong-Baker scale, ranged 0-10. Higher scores correspond to higher levels of pain.
Reduction in pain score, age 8-18 years
The score is evaluated using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.

Secondary Outcome Measures

Reduction in pain score, age 3-7 years
The score is evaluated using the Wong-Baker scale, ranged 0-10. Higher scores correspond to higher levels of pain.depending on age
Reduction in pain score, age 3-7 years
The score is evaluated using the Wong-Baker scale, ranged 0-10. Higher scores correspond to higher levels of pain.
Reduction in pain score, age 8-18 years
The score is evaluated using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.
Reduction in pain score, age 8-18 years
The score is evaluated using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.
Frequency of use of pain killer drugs
Number of postoperative pain killers drugs administered
Reduction in pain score evaluated by parents
Pain evaluated by parents using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.
Quality of sleep
The quality of children sleep will be evaluated by parents or caregivers through a questionnaire
Mean daily food intake.
The mean daily food intake of children will be evaluated by parents or caregivers through a questionnaire.
Frequency of use of pain killer drugs
The number of pain killers drugs administered at home will be measured by parents or caregivers.

Full Information

First Posted
December 31, 2020
Last Updated
August 22, 2023
Sponsor
IRCCS Burlo Garofolo
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1. Study Identification

Unique Protocol Identification Number
NCT04693208
Brief Title
Analgesic Effect of Laser Therapy in Children
Official Title
Analgesic Effect of Laser Therapy in Paediatric Patients Undergoing Tonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Adverse reactions (tonsillar bleeding after treatment)
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Burlo Garofolo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pain management after tonsillectomy could be challenging, with different protocols and various outcome depending on individual patient; moreover, odynophagia due to surgery can, in extreme cases, lead to block oral fluid intake, ending in dehydration and thus hospitalization. A small pilot study demonstrated efficacy of photo-biomodulation (PBM) in managing pain after tonsillectomy and it suggests that PBM can be included in clinical practice. The present research aims to confirm and expand the findings from this study, being the first step in including PBM in clinical routine after tonsillectomy. Use of this treatment, which is non-damaging, non-toxic and easy to supply to patients, could greatly improve individual quality of life after a surgical treatment; its use in the clinical practice could represent an advantage for the institute, leading to more patients' satisfaction, due to the lower pain sensation after surgery and quicker recovery time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Pain, Tonsillectomy, Laser Therapy, Photo-biomodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser
Arm Type
Experimental
Arm Description
Laser light will be applied to the surgery site after tonsils excision.
Arm Title
Standard care
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Laser therapy
Intervention Description
Laser treatment parameters will be two combined wavelength (660 and 970 nm), 3.2 Watt peak power, 320 milliWatt/cm2, 36.8 Joule/cm2 fluency, and 50% frequency, for a total time of 3 minutes for each site
Primary Outcome Measure Information:
Title
Reduction in pain score, age 3-7 years
Description
The score is evaluated using the Wong-Baker scale, ranged 0-10. Higher scores correspond to higher levels of pain.
Time Frame
After 24 hours
Title
Reduction in pain score, age 8-18 years
Description
The score is evaluated using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.
Time Frame
After 24 hours
Secondary Outcome Measure Information:
Title
Reduction in pain score, age 3-7 years
Description
The score is evaluated using the Wong-Baker scale, ranged 0-10. Higher scores correspond to higher levels of pain.depending on age
Time Frame
After 4 hours
Title
Reduction in pain score, age 3-7 years
Description
The score is evaluated using the Wong-Baker scale, ranged 0-10. Higher scores correspond to higher levels of pain.
Time Frame
After 6 hours
Title
Reduction in pain score, age 8-18 years
Description
The score is evaluated using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.
Time Frame
After 4 hours
Title
Reduction in pain score, age 8-18 years
Description
The score is evaluated using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.
Time Frame
After 6 hours
Title
Frequency of use of pain killer drugs
Description
Number of postoperative pain killers drugs administered
Time Frame
Within 24 hours
Title
Reduction in pain score evaluated by parents
Description
Pain evaluated by parents using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.
Time Frame
7 days after discharge
Title
Quality of sleep
Description
The quality of children sleep will be evaluated by parents or caregivers through a questionnaire
Time Frame
7 days after discharge
Title
Mean daily food intake.
Description
The mean daily food intake of children will be evaluated by parents or caregivers through a questionnaire.
Time Frame
7 days after discharge
Title
Frequency of use of pain killer drugs
Description
The number of pain killers drugs administered at home will be measured by parents or caregivers.
Time Frame
7 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Tonsillectomy or adenotonsillectomy due to apneic chronic snoring and/or obstructive sleep apnea and/or recurrent tonsillitis Exclusion Criteria: American Society of Anesthesiologists (ASA) Score > 2 Neuropsychiatric co-morbidity Pro-hemorrhage coagulation disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raffaella Sagredini, MD
Organizational Affiliation
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eva Orzan, MD
Organizational Affiliation
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
City
Trieste
ZIP/Postal Code
34137
Country
Italy

12. IPD Sharing Statement

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Analgesic Effect of Laser Therapy in Children

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