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

Cairo University (CU)

Status: Unknown

Conditions: Blood Loss, Surgical; Scoliosis

Treatments: Drug: Tranexamic acid injection; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04622397

tranexamic acid in scoliosis

Details and patient eligibility

About

We hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Group T (tranexamic acid),n=15

Active Comparator group

Description:

Group T: tranexamic acid 10 mg/kg will be injected locally

Treatment:

Drug: Tranexamic acid injection

Group S (saline) (n=15)

Placebo Comparator group

Description:

Group S saline will be injected

Treatment:

Drug: Saline