Analgesic Effect of Laser Therapy in Children

Pain, Postoperative Clinical Trial

Official title:

Analgesic Effect of Laser Therapy in Paediatric Patients Undergoing Tonsillectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04693208
• Other study ID #: RC 02/2020
• Status: Terminated
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2023
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Italy	Institute for Maternal and Child Health - IRCCS Burlo Garofolo-	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Frequency of use of pain killer drugs	Number of postoperative pain killers drugs administered	Within 24 hours
Secondary	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
Secondary	Quality of sleep	The quality of children sleep will be evaluated by parents or caregivers through a questionnaire	7 days after discharge
Secondary	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
Secondary	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