Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

NCT02703415 | Completed Phase 2 DMC

• 1 other identifier: IRB000087400
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Pain

Keywords

immune; interleukin; tramadol; postoperartive analgesia; pediatric; caudal bupivacaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• . Post operative pain intensity

  within the first postoperative day

• Time of first supplemental analgesia

  within the first postoperative day

• sedation score

  Within the first 24 hours

• side effects

  Within the first 24 hours

• Leucocyte count

  within the first three days postoperatiely

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

caudal Bupivacaine

Drug: Bupivacaine

Tramadol

ACTIVE COMPARATOR

caudal Tramadol

Drug: Bupivacaine; Drug: Tramadol

Interventions

Bupivacaine DRUG

caudal block with bupivacaine (0.25%) 1mg/kg

Also known as: Marcaine

Bupivacaine; Tramadol

Tramadol DRUG

caudal block with tramadol 1 mg/kg

Also known as: Tamol

Tramadol

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• lower abdominal operation

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Bupivacaine; Tramadol; tamol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• sayed abd elshafy

  associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 9, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

EG (1)