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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine
Ketamine
Bupivacaine
Bupivacaine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring anesthesia, analgesia, caudal, ketamine, bupivacaine

Eligibility Criteria

6 Months - 6 Years (Child)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut university hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Topical ketamine and topical bupivacaine

Caudal ketamine and caudal bupivacaine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

time to first request for postoperative analgesia
time in hours from admission to PACU till first request for analgesia

Secondary Outcome Measures

total consumption of postoperative analgesics
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
Faces Legs Activity Cry Consolability tool (FLACC, 0-10).
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).
parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor).
the score will be recorded once at the end of the study
noninvasive blood pressure
heart rate
Verbal Numeric Rating Scale (VNRS)
the pain score will be assessed at frequent intervals in the 1st 48 h postoperative

Full Information

First Posted
May 29, 2015
Last Updated
October 1, 2015
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02462174
Brief Title
Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy
Acronym
TKversusCK
Official Title
Caudal Epidural Block Versus Topical Ketamine Application for Postoperative Pain Relief After Elective Inguinal Herniotomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
anesthesia, analgesia, caudal, ketamine, bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical ketamine and topical bupivacaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Caudal ketamine and caudal bupivacaine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Katalar
Intervention Description
0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Katalar
Intervention Description
0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
bucaine
Intervention Description
1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
bucaine
Intervention Description
0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure
Primary Outcome Measure Information:
Title
time to first request for postoperative analgesia
Description
time in hours from admission to PACU till first request for analgesia
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
total consumption of postoperative analgesics
Description
the amount of analgesic drugs in mg given in the first 48h postoperative
Time Frame
48 hours postoperative
Title
The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score
Time Frame
180 minutes postoperative
Title
Faces Legs Activity Cry Consolability tool (FLACC, 0-10).
Time Frame
180 minutes postoperative.
Title
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
Title
parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor).
Description
the score will be recorded once at the end of the study
Time Frame
48 hours postoperative
Title
noninvasive blood pressure
Time Frame
Intra-operative
Title
heart rate
Time Frame
Intra-operative
Title
Verbal Numeric Rating Scale (VNRS)
Description
the pain score will be assessed at frequent intervals in the 1st 48 h postoperative
Time Frame
48 hours postoperative

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age (6 months to 6 years) ASA physical status I or II. Operation: elective unilateral inguinal herniotomy. Exclusion Criteria: A history of developmental delay or mental retardation, Known or suspected coagulopathy, Known allergy to any local anaesthetic, Known congenital anomaly of the spine or signs of spinal anomaly, Infection at the sacral region.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala S Abdel-Ghaffar, MD
Organizational Affiliation
Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
State/Province
Assiut governorate
ZIP/Postal Code
715715
Country
Egypt

12. IPD Sharing Statement

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

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