A Phase 4 interventional study of Bupivacaine 0.5% and Bupivacaine 0.5% , Dexamethasone in Tonsillectomy, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-02-23.
Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Phase 4, Interventional, and Other
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% .
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.
Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 114 studies on the registry; 15 are open to participants now.
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Tonsillectomy surgery for recurrent tonsillitis Sleep disorder breathing
ExclusionCriteria:
Patients with active upper respiratory tract infection Patients with significant cognitive impairment Bupivacaine Dexamethasone hypersensitivity Taking chronic systemic
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nacl 0,9% 3-5 ml separately two part for each tonsil before surgery
Drug: Nacl 0,9 %
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%
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
Marcaine 0.5% Injectable Solution
Also known as: Marcaine 0,5%
Bupivacaine 0.5% , Dexamethasone
Also known as: Dekort, Marcaine 0,5 % Injectable Solution
Injectable Solution
Also known as: Serum Physiologic
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
Time frame: postoperative 7day .
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
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: postop seven day
Plan to share: No — There is no plan to make individual participant (IPD) to the other researchers
Started Dec 2017 (actual). Primary completion is estimated for Mar 2018, 3 months after the start.
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Studies of the drug tested here: Bupivacaine
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