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Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline

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ClinicalTrials.gov Identifier: NCT05444036
Recruitment Status : Completed
First Posted : July 5, 2022
Last Update Posted : September 10, 2022
Sponsor:
Information provided by (Responsible Party):
Egymedicalpedia

Tracking Information
First Submitted Date  ICMJE June 21, 2022
First Posted Date  ICMJE July 5, 2022
Last Update Posted Date September 10, 2022
Actual Study Start Date  ICMJE September 1, 2018
Actual Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2022)
Measurement of Post-operative Pain [ Time Frame: 24-hour analgesic after surgery ]
Assessment of the pain post-operatively in Pediatric patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain, measured in millimetres from the left end bar to the mark placed by the kid on the 10 cm line anchored by happy faces (no pain) to sad faces (severe pain).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline
Official Title  ICMJE Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline in Pediatric Surgical Procedures Below the Umbilicus
Brief Summary

Because pain is difficult to measure in children, post-operative pain is frequently undertreated in this age range. Pain treatment is required in children due to the high emotional component of pain. Pain is a multidimensional, subjective, perceptual event having a variety of qualities such as intensity, quality, time course, and effects that are perceived differently by each person. Because the operational definition of pain necessitates self-report, pain experienced by children and babies is frequently overlooked, if not ignored.

When general anesthesia is paired with regional procedures, children of all ages are exposed to less intravenous and inhalational anesthetics and analgesics, leaving them nearly free of nausea, vomiting, itching, or unneeded drowsiness. Being completely awake and able to drink soon after surgery, as well as having no issues breathing even after lengthy surgery, are significant benefits that children and parents value.

Detailed Description

Caudal block provides the potential benefit of extending the length and effectiveness of the block by combining additional medications with the local anaesthetic agent. Morphine, clonidine, ketamine, and midazolam were among the drugs used.

Although peripheral nerve blocks and caudal anesthesia are relatively safe, extreme attention is required to minimize adverse consequences. Pediatric anesthesiologists must have adequate training to ensure patient safety. A well-trained pediatric anesthesiologist will try to avoid unsafe regional anesthetic application methods and will always be prepared to manage dangerous side effects (overdoses, intravenous administration induced seizures, tip displacement of epidural catheters or centrally located abscesses).

Ketamine is a non-competitive N-methyl D-aspartate NMDA receptor antagonist that is thought to prevent or reverse central sensitization and, as a result, lessen postoperative pain. It also has a peripheral analgesic effect.

Ketamine infiltration has been demonstrated to provide pain alleviation in children having adenotonsillectomy for up to 24 hours following surgery with no adverse effects.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
comparing caudal block by bupivacaine with and without ketamine in paediatric patients undergoing surgery below the umbilicus with regard to analgesic, anaesthetic, and sedative properties.
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Surgery
  • Pediatric Surgery
Intervention  ICMJE Drug: Ketamine
compare caudal ketamine-bupivacaine against caudal bupivacaine-saline in paediatric Measuring pain in patients undergoing surgery below the umbilicus with regard to analgesic, anaesthetic, and sedative properties
Study Arms  ICMJE
  • Experimental: Ketamin-bupivacaine Group
    in this method,30 patients which received 0.5 mg/kg of preservative free ketamine (i.e. 0.05ml/kg of 10mg/ml ketamine diluted up to 1ml in normal saline) plus1ml/kg of 0.25 % bupivacaine caudally, after induction of general anaesthesia
    Intervention: Drug: Ketamine
  • Experimental: bupivacaine-saline Group
    30 patients received 1ml/kg of 0.25 % bupivacaine plus 1ml of normal saline caudally of just after induction of general anaesthesia, just after induction of general anaesthesia
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2022)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2019
Actual Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1- All children whom were diagnosed with herniotomy, orchidopexy, or urethroplasty.

Exclusion Criteria:

  1. Drugs used allergy or sensitivity,
  2. contraindications to caudal injection, such as infection at the injection site,
  3. bleeding disorders
  4. caudal vertebral abnormalities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05444036
Other Study ID Numbers  ICMJE NIRVANA 2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Egymedicalpedia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Egymedicalpedia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nirvana Elshalakany, Professor Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt
PRS Account Egymedicalpedia
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP