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Transversus Abdominis Plane Block In Children

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ClinicalTrials.gov Identifier: NCT02990975
Recruitment Status : Unknown
Verified December 2016 by ILKE KUPELI, Erzincan University.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
ILKE KUPELI, Erzincan University

Brief Summary:
Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis Plane Block supported by ketamine sedation only.

Condition or disease Intervention/treatment Phase
Intra-operative Anesthesia Drug: ketamine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Ultrasonography Guided Transversus Abdominis Plane Block to Intraoperative Anesthesia in Children: Randomized Controlled Study
Study Start Date : December 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: block and ketamine
Transversus Abdominis Plane block after ketamine atropine induction and continued with ketamine only in anesthesia
Drug: ketamine
Active Comparator: ketamine atropine; laryngeal mask
After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and applied Transversus Abdominis Plane block.
Drug: ketamine
Active Comparator: control group
After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and Non-block, postoperative analgesia with paracetamol IV
Drug: ketamine



Primary Outcome Measures :
  1. the amount of anesthetic drug which was used [ Time Frame: two hour ]

Secondary Outcome Measures :
  1. Postoperative visual analogue scale [ Time Frame: one day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II
  • To undergo elective lower abdominal surgery
  • between 2-6 years old

Exclusion Criteria:

  • Patients with psychiatric disease
  • Patients whose weight is more than 40 kg
  • Patients with cardiac-pulmonary-neurological disease
  • Patients with bleeding disorder
  • Patients with infection or scar on the injection area
  • Patients with known allergies to local anesthetics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990975


Sponsors and Collaborators
Erzincan University
Investigators
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Principal Investigator: ilke kupeli Erzincan University

Publications:

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Responsible Party: ILKE KUPELI, assist. prof., Erzincan University
ClinicalTrials.gov Identifier: NCT02990975     History of Changes
Other Study ID Numbers: ERZINCAN UNIVERSITY 7
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ILKE KUPELI, Erzincan University:
Intra-operative anesthesia
Pediatric patient
Transversus Abdominis Plane Block

Additional relevant MeSH terms:
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Anesthetics
Ketamine
Atropine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents