Analgesic Effect of Laser Therapy in Children

Not Applicable

Terminated

• Conditions: Pain, Postoperative
• Interventions: Device: Laser therapy

• Registration Number: NCT04693208
• Lead Sponsor: IRCCS Burlo Garofolo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Study Start: 2021-01-11
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	Laser therapy	Laser light will be applied to the surgery site after tonsils excision.

Primary Outcome Measures

Name	Time	Method
Reduction in pain score, age 3-7 years	After 24 hours	The score is evaluated using the Wong-Baker scale, ranged 0-10. Higher scores correspond to higher levels of pain.
Reduction in pain score, age 8-18 years	After 24 hours	The score is evaluated using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.

Secondary Outcome Measures

Name	Time	Method
Reduction in pain score, age 3-7 years	After 6 hours	The score is evaluated using the Wong-Baker scale, ranged 0-10. Higher scores correspond to higher levels of pain.
Reduction in pain score evaluated by parents	7 days after discharge	Pain evaluated by parents using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.
Frequency of use of pain killer drugs	7 days after discharge	The number of pain killers drugs administered at home will be measured by parents or caregivers.
Reduction in pain score, age 8-18 years	After 6 hours	The score is evaluated using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.
Quality of sleep	7 days after discharge	The quality of children sleep will be evaluated by parents or caregivers through a questionnaire
Mean daily food intake.	7 days after discharge	The mean daily food intake of children will be evaluated by parents or caregivers through a questionnaire.

Trial Locations

Locations (1)

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-; 🇮🇹 Trieste, Italy