---
title: Analgesic Effect of Laser Therapy in Children
nct_id: NCT04693208
overall_status: TERMINATED
phase: NA
sponsor: IRCCS Burlo Garofolo
study_type: INTERVENTIONAL
primary_condition: Pain, Postoperative
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04693208.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04693208"
ct_last_update_post_date: 2023-08-24
last_seen_at: "2026-05-12T06:47:57.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Analgesic Effect of Laser Therapy in Children

**Official Title:** Analgesic Effect of Laser Therapy in Paediatric Patients Undergoing Tonsillectomy

**NCT ID:** [NCT04693208](https://clinicaltrials.gov/study/NCT04693208)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Adverse reactions (tonsillar bleeding after treatment)
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 22
- **Lead Sponsor:** IRCCS Burlo Garofolo
- **Conditions:** Pain, Postoperative
- **Start Date:** 2021-01-11
- **Completion Date:** 2021-05-31
- **CT.gov Last Update:** 2023-08-24

## 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.

## Eligibility

- **Minimum age:** 3 Years
- **Maximum age:** 18 Years
- **Sex:** ALL
- **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
```

## Arms

- **Laser** (EXPERIMENTAL) — Laser light will be applied to the surgery site after tonsils excision.
- **Standard care** (NO_INTERVENTION)

## Interventions

- **Laser therapy** (DEVICE) — 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

## Primary Outcomes

- **Reduction in pain score, age 3-7 years** _(time frame: 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** _(time frame: 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 Outcomes

- **Reduction in pain score, age 3-7 years** _(time frame: After 4 hours)_
- **Reduction in pain score, age 3-7 years** _(time frame: After 6 hours)_
- **Reduction in pain score, age 8-18 years** _(time frame: After 4 hours)_
- **Reduction in pain score, age 8-18 years** _(time frame: After 6 hours)_
- **Frequency of use of pain killer drugs** _(time frame: Within 24 hours)_
- **Reduction in pain score evaluated by parents** _(time frame: 7 days after discharge)_
- **Quality of sleep** _(time frame: 7 days after discharge)_
- **Mean daily food intake.** _(time frame: 7 days after discharge)_
- **Frequency of use of pain killer drugs** _(time frame: 7 days after discharge)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.institute for maternal and child health - irccs burlo garofolo-|trieste||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04693208.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04693208*  
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