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Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

Primary Purpose

Acute Pain

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

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring immune, interleukin, tramadol, postoperartive analgesia, pediatric, caudal bupivacaine

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

lower abdominal operation

Exclusion Criteria:

Any systemic disease that might compromise the immune system severe coagulation disorder true allergy to local anesthetics patients with major malformations of the lower spine or meninges any cutaneous or subcutaneous lesion at the site of injection unplanned reoperation, or reoperation within three months Diabetes Melliutes

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bupivacaine

Tramadol

Arm Description

caudal Bupivacaine

caudal Tramadol

Outcomes

Primary Outcome Measures

post operative immune response
post operative immune response by measuring interleukin 6 (IL-6) using enzyme-linked immunosorbent assay (ELISA) technique, serum cortisol, C-reactive protein (CRP), and phopholipase A2 (PLA2) one hour preoperatively, end of anesthesia, 1st post- operative day, and 3rd post- operative day

Secondary Outcome Measures

. Post operative pain intensity
Post operative pain intensity with the FLACC pain scale for five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) consolability will be assessed.
Time of first supplemental analgesia
Time of first supplemental analgesia
sedation score
Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)
side effects
hypotension, vomiting, pruritus, urinary retention or motor weakness will be recorded.
Leucocyte count
Leucocyte count and the percentages of neutrophils, lymphocytes and monocytes at one hour preoperatively, end of anesthesia, 1st post- operative day, and 3rd post- operative day

Full Information

First Posted
March 4, 2016
Last Updated
October 18, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02703415
Brief Title
Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery
Official Title
Comparison Of Immune Response And Analgesic Effects Of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (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
Management of acute pain is one of the most important tasks of perioperative pediatric anesthesia. The alleviation of pain has been defined by the Society of Pediatric Anesthesia, on its 15th annual meeting as a basic human right, irrespective of age, treatment primary service responsible for the patient care. Pro-inflammatory cytokines increased by surgical trauma indirectly modulate pain through the release of substances like nitric oxide, oxygen free radicals, prostaglandins, and excitatory amino acids, inducing peripheral and central sensitivity and hyperalgesia. There has been growing interest in determining the possible immune consequences of analgesic administration for the management of postoperative pain
Detailed Description
60 children aged 3-10 years undergoing lower abdominal surgery will be randomized into 2 groups (30 patients in each group) to receive caudal block with bupivacaine (0.25%) 1mg/kg (group 1) plus tramadol 1mg/kg (group 2) just after the induction of general anesthesia without premedication. All children will be assessed for the post operative immune response by measuring interleukin 6 and 10 (IL-6 and IL-10) and Tumour Necrosing Factor-α (TNF-α) using enzyme-linked immunosorbent assay (ELISA) technique one hour preoperatively and three hours after incision.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
immune, interleukin, tramadol, postoperartive analgesia, pediatric, caudal bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
caudal Bupivacaine
Arm Title
Tramadol
Arm Type
Active Comparator
Arm Description
caudal Tramadol
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
caudal block with bupivacaine (0.25%) 1mg/kg
Intervention Type
Drug
Intervention Name(s)
Tramadol
Other Intervention Name(s)
Tamol
Intervention Description
caudal block with tramadol 1 mg/kg
Primary Outcome Measure Information:
Title
post operative immune response
Description
post operative immune response by measuring interleukin 6 (IL-6) using enzyme-linked immunosorbent assay (ELISA) technique, serum cortisol, C-reactive protein (CRP), and phopholipase A2 (PLA2) one hour preoperatively, end of anesthesia, 1st post- operative day, and 3rd post- operative day
Time Frame
within the first three days postoperatiely
Secondary Outcome Measure Information:
Title
. Post operative pain intensity
Description
Post operative pain intensity with the FLACC pain scale for five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) consolability will be assessed.
Time Frame
within the first postoperative day
Title
Time of first supplemental analgesia
Description
Time of first supplemental analgesia
Time Frame
within the first postoperative day
Title
sedation score
Description
Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)
Time Frame
Within the first 24 hours
Title
side effects
Description
hypotension, vomiting, pruritus, urinary retention or motor weakness will be recorded.
Time Frame
Within the first 24 hours
Title
Leucocyte count
Description
Leucocyte count and the percentages of neutrophils, lymphocytes and monocytes at one hour preoperatively, end of anesthesia, 1st post- operative day, and 3rd post- operative day
Time Frame
within the first three days postoperatiely

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: lower abdominal operation Exclusion Criteria: Any systemic disease that might compromise the immune system severe coagulation disorder true allergy to local anesthetics patients with major malformations of the lower spine or meninges any cutaneous or subcutaneous lesion at the site of injection unplanned reoperation, or reoperation within three months Diabetes Melliutes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sayed abd elshafy
Organizational Affiliation
associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

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