Postoperative Pain Control by Adding Ketorolac to Bupivacaine in Transversus Abdominis Plane Block in Children

Efficacy of Ketorolac When Added to Bupivacaine in Transversus Abdominis Plane Block in Children

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)

Study Overview

• Status: Completed
• Conditions: Postoperative Pain, Acute
• Intervention / Treatment: Drug: Ketorolac; Drug: Bupivacain

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 52514
    • Fouad Ibrahim Soliman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAP block with bupivacaine and ketorolac; Ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).	Drug: Ketorolac; analgesia; Drug: Bupivacain; analgesia; Other Names: bupivacaine
Active Comparator: TAP block with bupivacaine; ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg).	Drug: Bupivacain; analgesia; Other Names: bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1st analgesic requirement	the time at which the 1st need for analgesia is given.	24 hours
Number of patients who requested analgesia	Number (percentage)of patients who requested analgesia	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	the patient vital sign (beats/min)	24 hours
Total rescue analgesia	Total rescue analgesia in the first 24 h. postoperatively	24 hours
Satisfaction of the parents regarding their children analgesia	using 5- point satisfaction scale (1= Very satisfied, 2=Satisfied,3= Neither satisfied nor dissatisfied,4= Dissatisfied, 5= Very dissatisfied). This satisfaction will be done by parents according to the VAS, incidence of side effects and analgesic requirements	24 hours
Number of children in each group who required analgesia in the first 24 h postoperatively	Number of children in each group who required analgesia in the first 24h postoperatively	24 hours
blood pressure	The patients blood pressure (mmHg)	24 hours

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Fouad I Soliman, MD, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 10, 2023

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; children; ketorolac; bupivacaine,; TAP
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anesthetics, Local; Ketorolac; Bupivacaine
• Other Study ID Numbers: 2010 (Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No