TonsillectomyPhase 4NCT03443778

Dexamethasone-bupivacaine Versus Bupivacaine for Tonsillectomy Pain.

A Phase 4 study testing Bupivacaine 0.5%, Bupivacaine 0.5% , Dexamethasone and Nacl 0,9 % in people with Tonsillectomy, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Investigators compared in this study peritonsillar infiltration of bupivacaine %0.5 (n=40 participants) versus bupivacaine % 0.5 and dexamethasone (number 40participants ) before surgery for reduce posttonsillectomy pain.And control group (n= 40participants) participants received peritonsillar Nacl 0,9% . Read more about this study

Who is it for?: Ages 2 to 12 years
Conditions the study is for: Tonsillectomy
What is being tested?: Bupivacaine 0.5%, Bupivacaine 0.5% , Dexamethasone and Nacl 0,9 %
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Dec 2017to 15 Apr 2018
Phase: Phase 4
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 2 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Tonsillectomy surgery for recurrent tonsillitis Sleep disorder breathing
ExclusionCriteria:
Patients with active upper respiratory tract infection Patients with significant cognitive impairment Bupivacaine hypersensitivity Dexamethasone hypersensitivity Taking chronic systemic steroids

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Leyla Kilinc
Istanbul, Sisli, 34360

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Peritonsillar Dexamethasone-bupivacaine and Bupivacaine Infiltration for Tonsillectomy Pain Relief in Children:a Randomized,Double Blind,Controlled Study.

Read the detailed description

Bupivacaine hydrochloride amid structure,long acting local anesthetic. Dexamethasone has strong anti-inflammatory drug reduce postoperative pain and nause and vomiting.Preoperative iv dexamethasone is routinely using for reduce tonsillectomy pain.Lots of studies show that adding dexamethasone to local anesthetic at peripheral nerve block prolongs the analgesic effect.Also preoperative iv dexamethasone prolongs the analgesic effects of local anesthetic infiltration .

Post tonsillectomy pain still a serious problem ,it effects postoperative morbidity.Different medicine combination used to applies for peritonsillar infiltration and multimodal iv and oral medication to reduce posttonsillectomy pain.İn this study investigators will use iv dexamethasone for all participants and investigators hypothesis that adding dexamethasone to bupivacaine for peritonsillar infiltration will reduce postoperative pain scores , consumption of rescue analgesic ,patient and family satisfaction.

Conditions: Tonsillectomy
Being tested: Bupivacaine 0.5%, Bupivacaine 0.5% , Dexamethasone, Nacl 0,9 %
Keywords: tonsillectomy pain, dexamethasone, bupivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine 0.5%Drug
Also called Marcaine 0,5%
Marcaine 0.5% Injectable Solution
Bupivacaine 0.5% , DexamethasoneDrug
Also called Dekort, Marcaine 0,5 % Injectable Solution
Bupivacaine 0.5% , Dexamethasone
Nacl 0,9 %Drug
Also called Serum Physiologic
Injectable Solution

Study groups in NCT03443778
Study group	Role	What they receive
Nacl 0,9% (Control) group	Active comparator	Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery Receives: Drug: Nacl 0,9 %
Bupivacaine 0,5%	Active comparator	Bupivacaine 0.5% 1 mg/kg with in Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery Receives: Drug: Bupivacaine 0.5%
Bupivacaine 0,5% , Dexamethasone	Active comparator	Bupivacaine 0,5% 1 mg/kg,dexamethasone 0.5 mg/kg (max dosage 8mg) 3-5 ml separately two part for each tonsil before surgery Receives: Drug: Bupivacaine 0.5% , Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of moderate/severe pain(>/= 4 of 10 Pain Scores)
Pain Scores will measure ; Face, Leg, Activity, Cry, Consolability score (FLACC) Interpreting the Score 0 Relaxed \& comfortable
1 - 3 = Mild discomfort 4 - 6 = Moderate pain 7 -10 = Severe pain or discomfort or both . 0 score is the best ,10 score is the worse score. 4 and up scores will considered to be the range to be treated .Pain score will measure at home ; Face Pain Scale 0 no pain 10 worse pain. Every day in the morning after phone call pain scores will ask patient/patient guardians. 4 and up scores will treated
Measured: postoperative 7day .

Secondary outcomes (5)

Side effects (nause,vomiting)
Nause will measure with visual analog scale (VAS) . 0 is the best 10 is the worse score. vomiting will measure with present/absent
Measured: postop seven day
Rescue analgesic consumption at PACU (post-anaesthesia care unit)
Pain Scores will measure ; Face, Leg, Activity, Cry, Consolability score (FLACC) Interpreting the Score 0 Relaxed \& comfortable
1 - 3 = Mild discomfort 4 - 6 = Moderate pain 7 -10 = Severe pain or discomfort or both . 0 score is the best ,10 score is the worse score. 4 and up scores will considered to be the range to be treated with iv paracetamol (10 mg/kg maximum Daily dosage) . İf the pain score is still 4 and up it will treated with tramadol 1 mg/kg).
Measured: At Pacu 1 hour
Rescue analgesic consumption first day at hospital
Pain Scores will measure ; Face, Leg, Activity, Cry, Consolability score (FLACC) Interpreting the Score 0 Relaxed \& comfortable
1 - 3 = Mild discomfort 4 - 6 = Moderate pain 7 -10 = Severe pain or discomfort or both . 0 score is the best ,10 score is the worse score. 4 and up scores will treated with oral paracetamol (10 mg/kg)
Measured: 4,8,12,24 h at hospital in first postoperative day.
Rescue analgesic consumption at home
Pain Scores will measure ; Face Pain Scale 0 no pain 10 worse pain. 4 and up scores will treated with oral paracetamol (10 mg/kg)
Measured: postop 2-3-5-6- 7. day
Parents satisfaction
Parents satisfaction will measure visual analog scale (VAS) . 0 is the best 10 is the worse score.
Measured: postop seven day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 201715 Apr 2018

First posted23 Feb 2018
Study start15 Dec 2017
Primary completion15 Mar 2018 (estimated)
Study completion15 Apr 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for TonsillectomyStudies 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03443778
Sponsor's protocol ID: 907-12.12.2017
Status last verified: Feb 2018
First submitted: 27 Dec 2017
Last updated: 23 Feb 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no plan to make individual participant (IPD) to the other researchers

Publications

Bayram A, Dogan M, Cihan C, Karatas D, Gokahmetoglu G, Ozcan I. The Efficacy of Levobupivacaine Hydrochloride-Dexamethasone Infiltration for Post-Tonsillectomy Pain in Adults. J Craniofac Surg. 2015 Oct;26(7):e651-3. doi: 10.1097/SCS.0000000000001975.
PubMed 26468853
Basuni AS, Ezz HA, Albirmawy OA. Preoperative peritonsillar infiltration of dexamethasone and levobupivacaine reduces pediatric post-tonsillectomy pain: a double-blind prospective randomized clinical trial. J Anesth. 2013 Dec;27(6):844-9. doi: 10.1007/s00540-013-1638-0. Epub 2013 May 25.
PubMed 23708881

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Peritonsillar Dexamethasone-bupivacaine and Bupivacaine Infiltration for Tonsillectomy Pain Relief in Children:a Randomized,Double Blind,Controlled Study.
ClinicalTrials.gov ID: NCT03443778
Acronym / sponsor ID: 907-12.12.2017
Conditions: Tonsillectomy
Keywords: tonsillectomy pain, dexamethasone, bupivacaine
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
Study start: 15 Dec 2017 (actual)
Primary completion: 15 Mar 2018 (estimated)
Study completion: 15 Apr 2018 (estimated)
First posted: 23 Feb 2018 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Nacl 0,9% (Control) group	Active comparator	Drug: Nacl 0,9 %Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery
Bupivacaine 0,5%	Active comparator	Drug: Bupivacaine 0.5%Bupivacaine 0.5% 1 mg/kg with in Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery
Bupivacaine 0,5% , Dexamethasone	Active comparator	Drug: Bupivacaine 0.5% , DexamethasoneBupivacaine 0,5% 1 mg/kg,dexamethasone 0.5 mg/kg (max dosage 8mg) 3-5 ml separately two part for each tonsil before surgery

Who may qualify

Ages: 2 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Tonsillectomy surgery for recurrent tonsillitis Sleep disorder breathing
Patients with active upper respiratory tract infection Patients with significant cognitive impairment Bupivacaine hypersensitivity Dexamethasone hypersensitivity Taking chronic systemic steroids

Key exclusion criteria (0 listed)

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
Bupivacaine 0.5%Also: Marcaine 0,5%Marcaine 0.5% Injectable Solution	Drug	Bupivacaine 0,5%
Bupivacaine 0.5% , DexamethasoneAlso: Dekort, Marcaine 0,5 % Injectable SolutionBupivacaine 0.5% , Dexamethasone	Drug	Bupivacaine 0,5% , Dexamethasone
Nacl 0,9 %Also: Serum PhysiologicInjectable Solution	Drug	Nacl 0,9% (Control) group

Primary outcome

Incidence of moderate/severe pain(>/= 4 of 10 Pain Scores)
Time frame: postoperative 7day .
Pain Scores will measure ; Face, Leg, Activity, Cry, Consolability score (FLACC) Interpreting the Score 0 Relaxed \& comfortable 1 - 3 = Mild discomfort 4 - 6 = Moderate pain 7 -10 = Severe pain or discomfort or both . 0 score is the best ,10 score is the worse score. 4 and up scores will considered to be the range to be treated .Pain score will measure at home ; Face Pain Scale 0 no pain 10 worse pain. Every day in the morning after phone call pain scores will ask patient/patient guardians. 4 and up scores will treated

5 secondary outcomes

Side effects (nause,vomiting)
Time frame: postop seven day
Rescue analgesic consumption at PACU (post-anaesthesia care unit)
Time frame: At Pacu 1 hour
Rescue analgesic consumption first day at hospital
Time frame: 4,8,12,24 h at hospital in first postoperative day.
Rescue analgesic consumption at home
Time frame: postop 2-3-5-6- 7. day
Parents satisfaction
Time frame: postop seven day

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
Background: PubMed 26468853Bayram A, Dogan M, Cihan C, Karatas D, Gokahmetoglu G, Ozcan I. The Efficacy of Levobupivacaine Hydrochloride-Dexamethasone Infiltration for Post-Tonsillectomy Pain in Adults. J Craniofac Surg. 2015 Oct;26(7):e651-3. doi: 10.1097/SCS.0000000000001975.
Background: PubMed 23708881Basuni AS, Ezz HA, Albirmawy OA. Preoperative peritonsillar infiltration of dexamethasone and levobupivacaine reduces pediatric post-tonsillectomy pain: a double-blind prospective randomized clinical trial. J Anesth. 2013 Dec;27(6):844-9. doi: 10.1007/s00540-013-1638-0. Epub 2013 May 25.
Individual participant dataSharing planned: No. There is no plan to make individual participant (IPD) to the other researchers

Related trials for Tonsillectomy

Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
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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.

Leyla Kilinc, Md study director

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 23 Feb 2018. 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 Turkey (Türkiye). 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Incidence of moderate/severe pain(>/= 4 of 10 Pain Scores) (time frame: postoperative 7day .). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03443778, which also lists 2 linked publications.

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 23 Feb 2018.