cleft palate with or without cleft lip. Cleft palate, Cleft palate with cleft lip
Conditions
Interventions
Intervention 1: Control: patients befor incision received placebo(normal saline) acid at a dose of 10 mg/kg bolus followed by continuous infusion of 1 mg/kg/h until the end of the procedur. Interventi
Placebo
Treatment - Drugs
Control: patients befor incision received placebo(normal saline) acid at a dose of 10 mg/kg bolus followed by continuous infusion of 1 mg/kg/h until the end of the procedur.
Intervention: patients befor incision received tranexamic acid(Caspian Tamin Pharmaceutical Co.) at a dose of 10 mg/kg bolus followed by continuous infusion of 1 mg/kg/h until the end of the procedure
Sponsors
Vice Chancellor for research of Zahedan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Palatoplasty indication in patients with presence of congenital cleft palate (with or without associated cleft lip). Exclusion Criteria: Preoperative hemoglobin lower than 10 mg/dl or platelet count less than 100,000/mm3; Presence of coagulopathy caused by known coagulation cascade disorders or systemic diseases, or excessive bleeding history on previous occasions; History of bleeding disorders in first-degree relatives; Use of medications that may interfere with the coagulation cascade (platelet inhibitors or anticoagulants); Indication of secondary palatoplasty with the purpose of correction oro-nasal fistula; Known allergy to tranexamic acid; History of hematuria.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative bleeding. Timepoint: during surgery. Method of measurement: Intraoperative bleeding volume defined as the sum of the volume blood in the suction during the procedure and the volume of blood retained in the used gauze.;Operative duration. Timepoint: since anesthesia induction until patient exited from operation room. Method of measurement: Data collection form. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin(Hb). Timepoint: 6 hour after procedure. Method of measurement: Data collection form.;Bleeding requiring reoperative homeostasis. Timepoint: post operation. Method of measurement: Data collection form. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactGholam Ali Dashti Khavidaki
Zahedan University of Medical Sciences
Outcome results
None listed