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Analgesic Effect of Laser Therapy in Children

NCT04693208 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-08-24

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative

Interventions

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

Sponsors & Collaborators

  • IRCCS Burlo Garofolo

    lead OTHER

Principal Investigators

  • Raffaella Sagredini, MD · Institute for Maternal and Child Health IRCCS Burlo Garofolo

  • Eva Orzan, MD · Institute for Maternal and Child Health IRCCS Burlo Garofolo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04693208 on ClinicalTrials.gov