Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial

Study Overview
=================
Brief Summary
-----------------
We hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery

Detailed Description
-----------------
Spine surgery in paediatrics is frequently associated with substantial blood loss. Blood product adminestration in children has many complications that are not fully known. There are many modalities currently available to reduce blood loss in pediatric patients. Tranexamic acid is tissue plasminogen activator inhibitor that reduce perioperative blood loss. To date, no studies have investigated effect of local administration of tranexamic acid in pediatric population undergoing scoliosis surgery.

Official Title
-----------------
Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial

Conditions
-----------------
Blood Loss, Surgical, Scoliosis

Intervention / Treatment
-----------------
* Drug: Tranexamic acid injection
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 2-12 years Of both sexes American society of anesthesiologist (ASA) physical status classification class I Undergoing general anesthesia for scoliosis surgery Exclusion Criteria: Parents' refusal of regional block Known allergy to tranexamic acid Bleeding disorders (INR >1.4,Platelet count< 75000)

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized comparative study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group T (tranexamic acid),n=15<br>Group T: tranexamic acid 10 mg/kg will be injected locally | Drug: Tranexamic acid injection<br>* Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision<br>|
| Placebo Comparator: Group S (saline) (n=15)<br>Group S saline will be injected | Drug: Saline<br>* Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraperative blood loss in both groups | amount of blood/kg(ml/kg) | period of surgery(1-2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative blood loss | amount of blood in drain after surgery | 24 hours | 
| Blood product admenestration | units of blood given during surgery | duration of procedure(1-2 hours) |