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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 October 2015 |
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Main ID: |
NCT02462174 |
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Date of registration:
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29/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy
TKversusCK |
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Scientific title:
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Caudal Epidural Block Versus Topical Ketamine Application for Postoperative Pain Relief After Elective Inguinal Herniotomy |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02462174 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Hala S Abdel-Ghaffar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt |
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Months
Age maximum:
6 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Postoperative Pain
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Intervention(s)
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Drug: Ketamine
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Drug: Bupivacaine
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Primary Outcome(s)
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time to first request for postoperative analgesia
[Time Frame: 48 hours postoperative]
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Secondary Outcome(s)
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Faces Legs Activity Cry Consolability tool (FLACC, 0-10).
[Time Frame: 180 minutes postoperative.]
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noninvasive blood pressure
[Time Frame: Intra-operative]
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total consumption of postoperative analgesics
[Time Frame: 48 hours postoperative]
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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]
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Verbal Numeric Rating Scale (VNRS)
[Time Frame: 48 hours postoperative]
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heart rate
[Time Frame: Intra-operative]
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parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor).
[Time Frame: 48 hours postoperative]
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The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score
[Time Frame: 180 minutes postoperative]
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Secondary ID(s)
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IRB00008718/ NF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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