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

Not Applicable

• Conditions: Blood Loss, Surgical; Scoliosis
• Interventions: Drug: Tranexamic acid injection; Drug: Saline

• Registration Number: NCT04622397
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-04
• Last Update Submitted: 2020-11-04
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-10
• Study Start: 2021-01-10
• Primary Completion: 2021-11-29
• Study Completion: 2021-12-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T (tranexamic acid),n=15	Tranexamic acid injection	Group T: tranexamic acid 10 mg/kg will be injected locally
Group S (saline) (n=15)	Saline	Group S saline will be injected

Primary Outcome Measures

Name	Time	Method
Intraperative blood loss in both groups	period of surgery(1-2 hours)	amount of blood/kg(ml/kg)

Secondary Outcome Measures

Name	Time	Method
Blood product admenestration	duration of procedure(1-2 hours)	units of blood given during surgery
post-operative blood loss	24 hours	amount of blood in drain after surgery