Acute Pain
Conditions
Keywords
immune, interleukin, tramadol, postoperartive analgesia, pediatric, caudal bupivacaine
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
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.
Interventions
DRUGBupivacaine
caudal block with bupivacaine (0.25%) 1mg/kg
DRUGTramadol
caudal block with tramadol 1 mg/kg
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post operative immune response | 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
| Measure | Time frame | Description |
|---|---|---|
| Time of first supplemental analgesia | within the first postoperative day | Time of first supplemental analgesia |
| sedation score | Within the first 24 hours | Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS) |
| . Post operative pain intensity | 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. |
| side effects | Within the first 24 hours | hypotension, vomiting, pruritus, urinary retention or motor weakness will be recorded. |
| Leucocyte count | 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 |
Countries
Egypt
Outcome results
None listed