Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703415
• Other study ID #: IRB000087400
• Status: Completed
• Phase: Phase 2
• First received: March 4, 2016
• Last updated: October 18, 2017
• Start date: June 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• Bupivacaine
caudal block with bupivacaine (0.25%) 1mg/kg
• Tramadol
caudal block with tramadol 1 mg/kg

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	. 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
Secondary	Time of first supplemental analgesia	Time of first supplemental analgesia	within the first postoperative day
Secondary	sedation score	Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)	Within the first 24 hours
Secondary	side effects	hypotension, vomiting, pruritus, urinary retention or motor weakness will be recorded.	Within the first 24 hours
Secondary	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