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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

Brief Summary:
To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ketamine Drug: Bupivacaine Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Caudal Epidural Block Versus Topical Ketamine Application for Postoperative Pain Relief After Elective Inguinal Herniotomy
Study Start Date : May 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Ketamine
0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.
Other Name: Katalar

Drug: Bupivacaine
1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route
Other Name: bucaine

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.
Drug: Ketamine
0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.
Other Name: Katalar

Drug: Bupivacaine
0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure
Other Name: bucaine




Primary Outcome Measures :
  1. time to first request for postoperative analgesia [ Time Frame: 48 hours postoperative ]
    time in hours from admission to PACU till first request for analgesia


Secondary Outcome Measures :
  1. total consumption of postoperative analgesics [ Time Frame: 48 hours postoperative ]
    the amount of analgesic drugs in mg given in the first 48h postoperative

  2. The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score [ Time Frame: 180 minutes postoperative ]
  3. Faces Legs Activity Cry Consolability tool (FLACC, 0-10). [ Time Frame: 180 minutes postoperative. ]
  4. 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 ]
  5. 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

  6. noninvasive blood pressure [ Time Frame: Intra-operative ]
  7. heart rate [ Time Frame: Intra-operative ]
  8. 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



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

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.

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): NCT02462174


Locations
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Egypt
Assiut university hospitals
Assiut, Assiut governorate, Egypt, 715715
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Hala S Abdel-Ghaffar, MD Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
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Responsible Party: Hala Saad Abdel-Ghaffar, assistant professor anesthesia and intensive care department/ faculty of medicine/ Assiut university/ Egypt., Assiut University
ClinicalTrials.gov Identifier: NCT02462174    
Other Study ID Numbers: IRB00008718/ NF
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015
Keywords provided by Hala Saad Abdel-Ghaffar, Assiut University:
anesthesia
analgesia
caudal
ketamine
bupivacaine
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketamine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action