Clinical trial NCT06267820: Combined Ketorolac Bupivacaine Versus Bupivacaine Alone for TAP Block in Children Undergoing Lower Abdominal Surgeries
Official title: A Comparative Study Between Combined Ketorolac Bupivacaine and Bupivacaine Alone for Transversus Abdominis Plane Block in Children Undergoing Lower Abdominal Surgeries: A Prospective Double- Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain, Acute
Keywords: TAP
ketorolac
bupivacaine,
ultrasound
children
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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)

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: 1st analgesic requirement
timeFrame: 24 hours
measure: Number of patients who requested analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: heart rate
timeFrame: 24 hours
measure: Total rescue analgesia
timeFrame: 24 hours
measure: Satisfaction of the parents regarding their children analgesia
timeFrame: 24 hours
measure: Number of children in each group who required analgesia in the first 24 h postoperatively
timeFrame: 24 hours
measure: blood pressure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Fouad Ibrahim Soliman
Study officials:
affiliation: Sohag University
name: Fouad I Soliman, MD
role: PRINCIPAL_INVESTIGATOR
References: