Analgesic Effect of Laser Therapy in Children

IRCCS Burlo Garofolo

Status: Terminated

Conditions: Pain, Postoperative

Treatments: Device: Laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04693208

RC 02/2020

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Laser

Experimental group

Description:

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

Treatment:

Device: Laser therapy

Standard care

No Intervention group