Pain, Postoperative
Conditions
Keywords
Pain, Tonsillectomy, Laser Therapy, Photo-biomodulation
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.
Interventions
DEVICELaser 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
IRCCS Burlo Garofolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Frequency of use of pain killer drugs | Within 24 hours | Number of postoperative pain killers drugs administered |
| 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. |
| Reduction in pain score, age 3-7 years | After 4 hours | The score is evaluated using the Wong-Baker scale, ranged 0-10. Higher scores correspond to higher levels of pain.depending on age |
| 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. |
| Quality of sleep | 7 days after discharge | The quality of children sleep will be evaluated by parents or caregivers through a questionnaire |
| Reduction in pain score, age 8-18 years | After 4 hours | The score is evaluated using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain. |
Countries
Italy
Outcome results
None listed