Analgesic Effect of Laser Therapy in Children

Analgesic Effect of Laser Therapy in Paediatric Patients Undergoing Tonsillectomy

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.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative
• Intervention / Treatment: Device: Laser therapy

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raffaella Sagredini, MD; Phone Number: 00390403785111; Email: raffaella.sagredini@burlo.trieste.it
• Study Contact Backup: Name: Paola Staffa, MD; Phone Number: 00390403785111; Email: paola.staffa@burlo.trieste.it

Study Locations

• Italy
  • Trieste, Italy, 34137
    • Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care
Experimental: Laser; Laser light will be applied to the surgery site after tonsils excision.	Device: Laser therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 24 hours
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.	After 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	After 4 hours
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.	After 6 hours
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.	After 4 hours
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.	After 6 hours
Frequency of use of pain killer drugs	Number of postoperative pain killers drugs administered	Within 24 hours
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.	7 days after discharge
Quality of sleep	The quality of children sleep will be evaluated by parents or caregivers through a questionnaire	7 days after discharge
Mean daily food intake.	The mean daily food intake of children will be evaluated by parents or caregivers through a questionnaire.	7 days after discharge
Frequency of use of pain killer drugs	The number of pain killers drugs administered at home will be measured by parents or caregivers.	7 days after discharge

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Chair: Raffaella Sagredini, MD, Institute for Maternal and Child Health IRCCS Burlo Garofolo; Principal Investigator: Eva Orzan, MD, Institute for Maternal and Child Health IRCCS Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Tonsillectomy; Laser Therapy; Photo-biomodulation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: RC 02/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No