NCT04693208

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

December 31, 2020

Last Update Submit

August 22, 2023

Conditions

Pain, Postoperative

Keywords

PainTonsillectomyLaser TherapyPhoto-biomodulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Reduction in pain score, age 3-7 years

    After 4 hours

  • Reduction in pain score, age 3-7 years

    After 6 hours

  • Reduction in pain score, age 8-18 years

    After 4 hours

  • Reduction in pain score, age 8-18 years

    After 6 hours

  • Frequency of use of pain killer drugs

    Within 24 hours

  • +4 more secondary outcomes

Study Arms (2)

Laser

EXPERIMENTAL

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

Device: Laser therapy

Standard care

NO INTERVENTION

Interventions

Laser therapyDEVICE

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

Laser

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Tonsillectomy or adenotonsillectomy due to apneic chronic snoring and/or obstructive sleep apnea and/or recurrent tonsillitis

You may not qualify if:

  • American Society of Anesthesiologists (ASA) Score \> 2
  • Neuropsychiatric co-morbidity
  • Pro-hemorrhage coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, 34137, Italy

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Raffaella Sagredini, MD

    Institute for Maternal and Child Health IRCCS Burlo Garofolo

    STUDY CHAIR

  • Eva Orzan, MD

    Institute for Maternal and Child Health IRCCS Burlo Garofolo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 5, 2021

Study Start

January 11, 2021

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

August 24, 2023

Record last verified: 2023-08

Locations

IT(1)