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

S

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: Non-invasive blood pressure (systolic and diastolic). 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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