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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06267820
Enrollment
90
Registered
2024-02-20
Start date
2023-06-01
Completion date
2023-12-10
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Acute

Keywords

TAP, ketorolac, bupivacaine,, ultrasound, children

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

Interventions

DRUGBupivacain

analgesia

DRUGKetorolac

analgesia

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
1st analgesic requirement24 hoursthe time at which the 1st need for analgesia is given.
Number of patients who requested analgesia24 hoursNumber (percentage)of patients who requested analgesia

Secondary

MeasureTime frameDescription
Satisfaction of the parents regarding their children analgesia24 hoursusing 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
heart rate24 hoursthe patient vital sign (beats/min)
blood pressure24 hoursThe patients blood pressure (mmHg)
Number of children in each group who required analgesia in the first 24 h postoperatively24 hoursNumber of children in each group who required analgesia in the first 24h postoperatively
Total rescue analgesia24 hoursTotal rescue analgesia in the first 24 h. postoperatively

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026