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

NCT06267820 | Completed Phase 2 DMC

• 1 other identifier: 2010
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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)

Conditions

Postoperative Pain, Acute

Keywords

TAP; ketorolac; bupivacaine,; ultrasound; children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• heart rate

  24 hours

• Total rescue analgesia

  24 hours

• Satisfaction of the parents regarding their children analgesia

  24 hours

• Number of children in each group who required analgesia in the first 24 h postoperatively

  24 hours

• blood pressure

  24 hours

Study Arms (2)

TAP block with bupivacaine and ketorolac

ACTIVE COMPARATOR

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

Drug: Bupivacain; Drug: Ketorolac

TAP block with bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacain

Interventions

Bupivacain DRUG

analgesia

Also known as: bupivacaine

TAP block with bupivacaine; TAP block with bupivacaine and ketorolac

Ketorolac DRUG

analgesia

TAP block with bupivacaine and ketorolac

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Fouad Ibrahim Soliman

Sohag, 52514, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Ketorolac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fouad I Soliman, MD

  Sohag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and ICU

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: February 20, 2024
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 10, 2023
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

EG (1)