Pain, PostoperativeNCT04693208
Analgesic Effect of Laser Therapy in Children
A study testing Laser therapy in people with Pain, Postoperative, run by IRCCS Burlo Garofolo at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2021to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Tonsillectomy or adenotonsillectomy due to apneic chronic snoring and/or obstructive sleep apnea and/or recurrent tonsillitis
Who cannot join
- American Society of Anesthesiologists (ASA) Score > 2
- Neuropsychiatric co-morbidity
- Pro-hemorrhage coagulation disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Trieste, 34137
About this study
Official title: Analgesic Effect of Laser Therapy in Paediatric Patients Undergoing Tonsillectomy
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.
- Conditions
- Pain, Postoperative
- Being tested
- Laser therapy
- Keywords
- Pain, Tonsillectomy, Laser Therapy, Photo-biomodulation
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | Laser light will be applied to the surgery site after tonsils excision. Receives: Device: Laser therapy |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 24 hours
Secondary outcomes (9)
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
Measured: After 4 hours
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.
Measured: After 6 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.
Measured: After 4 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.
Measured: After 6 hours
Frequency of use of pain killer drugs
Number of postoperative pain killers drugs administered
Measured: Within 24 hours
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.
Measured: 7 days after discharge
Quality of sleep
The quality of children sleep will be evaluated by parents or caregivers through a questionnaire
Measured: 7 days after discharge
Mean daily food intake.
The mean daily food intake of children will be evaluated by parents or caregivers through a questionnaire.
Measured: 7 days after discharge
Frequency of use of pain killer drugs
The number of pain killers drugs administered at home will be measured by parents or caregivers.
Measured: 7 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start11 Jan 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Why it stopped: Adverse reactions (tonsillar bleeding after treatment)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raffaella Sagredini, MD, Study chair, Institute for Maternal and Child Health IRCCS Burlo GarofoloEva Orzan, MD, Principal investigator, Institute for Maternal and Child Health IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693208
- Sponsor's protocol ID
- RC 02/2020
- Status last verified
- Aug 2023
- First submitted
- 31 Dec 2020
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Laser Therapy in Paediatric Patients Undergoing Tonsillectomy
- ClinicalTrials.gov ID
- NCT04693208
- Acronym / sponsor ID
- RC 02/2020
- Conditions
- Pain, Postoperative
- Keywords
- Pain, Tonsillectomy, Laser Therapy, Photo-biomodulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adverse reactions (tonsillar bleeding after treatment)
- Enrolment
- 22 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Device: Laser therapyLaser light will be applied to the surgery site after tonsils excision. |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Tonsillectomy or adenotonsillectomy due to apneic chronic snoring and/or obstructive sleep apnea and/or recurrent tonsillitis
Key exclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) Score > 2
- Neuropsychiatric co-morbidity
- Pro-hemorrhage coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser therapyLaser 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 | Device | Laser |
Primary outcome
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.
9 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
Results and safety
The study was stopped early (reason given: Adverse reactions (tonsillar bleeding after treatment)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaella Sagredini, MD study chair
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Eva Orzan, MD principal investigator
Institute for Maternal and Child Health IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy in people with Pain, Postoperative, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Adverse reactions (tonsillar bleeding after treatment)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain score, age 3-7 years (time frame: After 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.