Analgesic Effect of Laser Therapy in Children

Study Overview
=================
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.

Official Title
-----------------
Analgesic Effect of Laser Therapy in Paediatric Patients Undergoing Tonsillectomy

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Device: Laser therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br>Laser light will be applied to the surgery site after tonsils excision. | Device: Laser therapy<br>* 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<br>|
| No Intervention: Standard care<br> | |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Tonsillectomy, Laser Therapy, Photo-biomodulation