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Completed

NCT Number: NCT02703415

Immune Response 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

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Key information

Conditions

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

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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

Other names: Marcaine

Tramadol

Drug

caudal block with tramadol 1 mg/kg

Other names: Tamol

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2016
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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