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Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy (TKversusCK)

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ClinicalTrials.gov Identifier: NCT02462174
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Hala Saad Abdel-Ghaffar, Assiut University

Tracking Information
First Submitted Date  ICMJE May 29, 2015
First Posted Date  ICMJE June 3, 2015
Last Update Posted Date October 2, 2015
Study Start Date  ICMJE May 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
time to first request for postoperative analgesia [ Time Frame: 48 hours postoperative ]
time in hours from admission to PACU till first request for analgesia
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
time to first request for postoperative analgesia [ Time Frame: 24 hours postoperative ]
time in hours from admission to PACU till first request for analgesia
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • total consumption of postoperative analgesics [ Time Frame: 48 hours postoperative ]
    the amount of analgesic drugs in mg given in the first 48h postoperative
  • The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score [ Time Frame: 180 minutes postoperative ]
  • Faces Legs Activity Cry Consolability tool (FLACC, 0-10). [ Time Frame: 180 minutes postoperative. ]
  • the agitation score (0= child is asleep, 1= awake/calm, 2= irritable/ consolable cry, 3=inconsolable cry, 4= the child is agitating and thrashing and restlessness). [ Time Frame: 60 minutes postoperative ]
  • parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor). [ Time Frame: 48 hours postoperative ]
    the score will be recorded once at the end of the study
  • noninvasive blood pressure [ Time Frame: Intra-operative ]
  • heart rate [ Time Frame: Intra-operative ]
  • Verbal Numeric Rating Scale (VNRS) [ Time Frame: 48 hours postoperative ]
    the pain score will be assessed at frequent intervals in the 1st 48 h postoperative
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
  • total consumption of postoperative analgesics [ Time Frame: 24 hours postoperative ]
    the amount of analgesic drugs in mg given in the first 24h postoperative
  • The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score [ Time Frame: 24 hours postoperative ]
  • Faces Legs Activity Cry Consolability tool (FLACC, 0-10). [ Time Frame: 24 hours postoperative. ]
  • the agitation score (0= child is asleep, 1= awake/calm, 2= irritable/ consolable cry, 3=inconsolable cry, 4= the child is agitating and thrashing and restlessness). [ Time Frame: 24 hours postoperative ]
  • parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor). [ Time Frame: 24 hours postoperative ]
    the score will be recorded once at the end of the study
  • noninvasive blood pressure [ Time Frame: 24 hours postoperative ]
  • heart rate [ Time Frame: 24 hours postoperative ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy
Official Title  ICMJE Caudal Epidural Block Versus Topical Ketamine Application for Postoperative Pain Relief After Elective Inguinal Herniotomy
Brief Summary To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.
Detailed Description The most commonly performed inguinal surgeries in children include inguinal hernia repair with or without orchidopexy (orchiopexy). Eighty children aged 6 months to 6 yr of ASA physical status I or II, undergoing elective unilateral inguinal herniotomy will be included. In caudal group, patients will receive a mixture of 0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route after anesthesia and before start of surgery. In topical group, at the end of the procedure, after identification and ligation of the hernial sac, a mixture of 0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord and upon the ilioinguinal nerve in a fan shaped manner by the surgeon. The primary outcome measure will be the time to first request for analgesia. Secondary outcome measures will include the number of analgesic doses required in the first 24 h postoperative, pain scores, sensory and motor block, agitation scores, parent satisfaction and adverse effects in the first 48h postoperative.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Ketamine
    0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.
    Other Name: Katalar
  • Drug: Ketamine
    0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.
    Other Name: Katalar
  • Drug: Bupivacaine
    1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route
    Other Name: bucaine
  • Drug: Bupivacaine
    0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure
    Other Name: bucaine
Study Arms  ICMJE
  • Active Comparator: Topical ketamine and topical bupivacaine
    0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered directly around the spermatic cord in the wound after end of surgery and before closure of the wound.
    Interventions:
    • Drug: Ketamine
    • Drug: Bupivacaine
  • Active Comparator: Caudal ketamine and caudal bupivacaine
    0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered by caudal epidural route after anesthesia and before the start of surgery.
    Interventions:
    • Drug: Ketamine
    • Drug: Bupivacaine
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 2, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. age (6 months to 6 years)
  2. ASA physical status I or II.
  3. Operation: elective unilateral inguinal herniotomy.

Exclusion Criteria:

  1. A history of developmental delay or mental retardation,
  2. Known or suspected coagulopathy,
  3. Known allergy to any local anaesthetic,
  4. Known congenital anomaly of the spine or signs of spinal anomaly,
  5. Infection at the sacral region.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 6 Months to 6 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 NCT02462174
Other Study ID Numbers  ICMJE IRB00008718/ NF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hala Saad Abdel-Ghaffar, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hala S Abdel-Ghaffar, MD Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
PRS Account Assiut University
Verification Date October 2015

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