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Trial record 54 of 451 for:    TRAMADOL

Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT02703415
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Sayed Kaoud Abd-Elshafy, Assiut University

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

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Bupivacaine Drug: Tramadol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Of Immune Response And Analgesic Effects Of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery
Study Start Date : June 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bupivacaine
caudal Bupivacaine
Drug: Bupivacaine
caudal block with bupivacaine (0.25%) 1mg/kg
Other Name: Marcaine

Active Comparator: Tramadol
caudal Tramadol
Drug: Bupivacaine
caudal block with bupivacaine (0.25%) 1mg/kg
Other Name: Marcaine

Drug: Tramadol
caudal block with tramadol 1 mg/kg
Other Name: Tamol




Primary Outcome Measures :
  1. post operative immune response [ Time Frame: within the first three days postoperatiely ]
    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 :
  1. . Post operative pain intensity [ Time Frame: within the first postoperative day ]
    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.

  2. Time of first supplemental analgesia [ Time Frame: within the first postoperative day ]
    Time of first supplemental analgesia

  3. sedation score [ Time Frame: Within the first 24 hours ]
    Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)

  4. side effects [ Time Frame: Within the first 24 hours ]
    hypotension, vomiting, pruritus, urinary retention or motor weakness will be recorded.

  5. Leucocyte count [ Time Frame: within the first three days postoperatiely ]
    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



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


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): NCT02703415


Locations
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Egypt
Faculty of Medicine
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: sayed abd elshafy associate professor

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Responsible Party: Sayed Kaoud Abd-Elshafy, Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT02703415     History of Changes
Other Study ID Numbers: IRB000087400
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sayed Kaoud Abd-Elshafy, Assiut University:
immune
interleukin
tramadol
postoperartive analgesia
pediatric
caudal bupivacaine
Additional relevant MeSH terms:
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Tramadol
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics