Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

Comparison Of Immune Response And Analgesic Effects Of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

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

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Bupivacaine; Drug: Tramadol

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine; caudal Bupivacaine	Drug: Bupivacaine; caudal block with bupivacaine (0.25%) 1mg/kg; Other Names: Marcaine
Active Comparator: Tramadol; caudal Tramadol	Drug: Bupivacaine; caudal block with bupivacaine (0.25%) 1mg/kg; Other Names: Marcaine; Drug: Tramadol; caudal block with tramadol 1 mg/kg; Other Names: Tamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within the first three days postoperatiely

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
. 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.	within the first postoperative day
Time of first supplemental analgesia	Time of first supplemental analgesia	within the first postoperative day
sedation score	Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)	Within the first 24 hours
side effects	hypotension, vomiting, pruritus, urinary retention or motor weakness will be recorded.	Within the first 24 hours
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	within the first three days postoperatiely

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: sayed abd elshafy, Associate Professor

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: pediatric; immune; tramadol; interleukin; postoperartive analgesia; caudal bupivacaine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Tramadol
• Other Study ID Numbers: IRB000087400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED