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Dexamethasone-bupivacaine Versus Bupivacaine for Tonsillectomy Pain.

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ClinicalTrials.gov Identifier: NCT03443778
Recruitment Status : Active, not recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Leyla Kılınc, Sisli Hamidiye Etfal Training and Research Hospital

Brief 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% .

Condition or disease Intervention/treatment Phase
Tonsillectomy Drug: Bupivacaine 0.5% Drug: Bupivacaine 0.5% , Dexamethasone Drug: Nacl 0,9 % Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Comparison of Peritonsillar Dexamethasone-bupivacaine and Bupivacaine Infiltration for Tonsillectomy Pain Relief in Children:a Randomized,Double Blind,Controlled Study.
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : March 15, 2018
Estimated Study Completion Date : April 15, 2018


Arm Intervention/treatment
Active Comparator: Nacl 0,9% (Control) group
Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery
Drug: Nacl 0,9 %
Injectable Solution
Other Name: Serum Physiologic

Active Comparator: 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
Drug: Bupivacaine 0.5%
Marcaine 0.5% Injectable Solution
Other Name: Marcaine 0,5%

Active Comparator: Bupivacaine 0,5% , Dexamethasone
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
Drug: Bupivacaine 0.5% , Dexamethasone
Bupivacaine 0.5% , Dexamethasone
Other Names:
  • Dekort
  • Marcaine 0,5 % Injectable Solution




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Side effects (nause,vomiting) [ Time Frame: postop seven day ]
    Nause will measure with visual analog scale (VAS) . 0 is the best 10 is the worse score. vomiting will measure with present/absent

  2. Rescue analgesic consumption at PACU (post-anaesthesia care unit) [ Time Frame: At Pacu 1 hour ]

    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).


  3. Rescue analgesic consumption first day at hospital [ Time Frame: 4,8,12,24 h at hospital in first postoperative day. ]

    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)


  4. Rescue analgesic consumption at home [ Time Frame: postop 2-3-5-6- 7. day ]
    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)

  5. Parents satisfaction [ Time Frame: postop seven day ]
    Parents satisfaction will measure visual analog scale (VAS) . 0 is the best 10 is the worse score.



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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443778


Locations
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Turkey
Leyla Kilinc
İstanbul, Sisli, Turkey, 34360
Sponsors and Collaborators
Sisli Hamidiye Etfal Training and Research Hospital
Investigators
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Study Director: Leyla Kilinc, Md Md

Publications:
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Responsible Party: Leyla Kılınc, Principal investigator, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03443778     History of Changes
Other Study ID Numbers: 907-12.12.2017
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant (IPD) to the other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Leyla Kılınc, Sisli Hamidiye Etfal Training and Research Hospital:
tonsillectomy pain
dexamethasone
bupivacaine

Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Bupivacaine
Pharmaceutical Solutions
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents