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Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

A

Assiut University

Status and phase

Completed
Phase 2

Conditions

Acute Pain

Treatments

Drug: Bupivacaine
Drug: Tramadol

Study type

Interventional

Funder types

Other

Identifiers

NCT02703415
IRB000087400

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

3 to 10 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Bupivacaine
Active Comparator group
Description:
caudal Bupivacaine
Treatment:
Drug: Bupivacaine
Tramadol
Active Comparator group
Description:
caudal Tramadol
Treatment:
Drug: Tramadol
Drug: Bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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