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NCT Number: NCT06267820

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

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)

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fouad Ibrahim Soliman

Sohag, 52514, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacain

Drug

analgesia

Other names: bupivacaine

Ketorolac

Drug

analgesia

Primary outcomes

  1. 1st analgesic requirement

    Time frame: 24 hours

    the time at which the 1st need for analgesia is given.

  2. Number of patients who requested analgesia

    Time frame: 24 hours

    Number (percentage)of patients who requested analgesia

Secondary outcomes

  1. heart rate

    Time frame: 24 hours

    the patient vital sign (beats/min)

  2. Total rescue analgesia

    Time frame: 24 hours

    Total rescue analgesia in the first 24 h. postoperatively

  3. Satisfaction of the parents regarding their children analgesia

    Time frame: 24 hours

    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

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

    Time frame: 24 hours

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

  5. blood pressure

    Time frame: 24 hours

    The patients blood pressure (mmHg)

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2024
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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