Combined Ketorolac Bupivacaine Versus Bupivacaine Alone for TAP Block in Children Undergoing Lower Abdominal Surgeries

Sohag University

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain, Acute

Treatments: Drug: Bupivacain; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT06267820

2010 (Other Identifier)

Details and patient eligibility

About

Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.

Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.

Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).

Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg)

Full description

This prospective randomized controlled study were carried out in Sohag university hospitals after getting approval from medical research ethics committee and written informed consents from the patients' parents or legal guardians. This study included 90 ASA status I and II children aged 6-12 years undergoing elective lower abdominal surgeries.Preoperative assessment:

• History taking from the parents.
• Complete physical examination.
• Laboratory investigations: Complete Blood Picture and coagulation profile. Preoperative preparation

Before starting, standard monitoring will be as follow:

1. Non-invasive blood pressure (systolic and diastolic).
2. Peripheral Oxygen saturation (SpO2%). After insertion of intravenous line, all children will receive atropine premedication (0.01-0.02 mg/kg). General anesthesia will be induced using propofol 1% (2 mg/kg), atracurium (0.5 mg/kg) to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane (1-2%) with controlled ventilation.At the end of operation, muscle relaxant is reversed using neostigmine and atropine.

Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).

Then TAP block were done under ultrasound guidance using either bupivacaine and ketorolac or bupivacaine alone

Enrollment: 90 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA status I and II children Age 6-12 years Elective lower abdominal surgeries.

Exclusion criteria

• Parents' or legal guardians' refusal.
• A history of developmental delay or mental retardation.
• ASA III and IV.
• A known allergy to ketorolac or bupivacaine.
• Hemodynamic unstable patient
• Urgent surgeries

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

90 participants in 2 patient groups

TAP block with bupivacaine and ketorolac

Active Comparator group

Description:

Ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).

Treatment:

Drug: Ketorolac

Drug: Bupivacain

TAP block with bupivacaine

Active Comparator group

Description:

ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg).

Treatment:

Drug: Bupivacain