Analgesic Effect of Laser Therapy in Children

NCT ID: NCT04693208

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-11

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Laser

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

Group Type EXPERIMENTAL

Laser therapy

Intervention Type DEVICE

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

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Burlo Garofolo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raffaella Sagredini, MD

Role: STUDY_CHAIR

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Eva Orzan, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Locations

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Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, , Italy

Site Status

Countries

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Italy

Other Identifiers

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RC 02/2020

Identifier Type: -

Identifier Source: org_study_id

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