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Surgical trauma initiates multiple physiological mechanisms that cause postoperative pain. Postoperative pain has nociceptive, inflammatory, and neuropathic components.Inadequate relief of postoperative pain leads to significant morbidity, delayed recovery, and mortality.Adverse reactions of medications used for postoperative pain management, particularly opioids, are common including pruritus and nausea and vomiting.Preemptive analgesia is defined as analgesic treatment that starts before surgical incision to prevent central sensitization caused by incisional and inflammatory injuries.Therefore, in this pilot study, the investigators are trying to evaluate safety and efficacy of preemptive multimodal analgesia compared with preemptive caudal analgesia and PCA morphine in pediatric cancer patient undergoing major abdominal surgery.
Surgical trauma initiates multiple physiological mechanisms that cause postoperative pain. Postoperative pain has nociceptive, inflammatory, and neuropathic components.Inadequate relief of postoperative pain leads to significant morbidity, delayed recovery, and mortality.Despite the development of new drugs and analgesic techniques, up to 40% of hospitalized children - especially surgical patients - experiences moderate to severe pain. Adverse reactions of medications used for postoperative pain management, particularly opioids, are common including pruritus and nausea and vomiting.The incidence of opioid-related respiratory depression was reported to range from 0.11 to 0.41%.Regional anesthesia was suggested as an alternative to opioid-based analgesia in pediatric patients. Caudal epidural analgesia is a relatively safe and simple technique for postoperative pain management in children.However, there is a potential for adverse effects related to the technique of catheter placement or systemic toxicity of the local anesthetic.
Preemptive analgesia is defined as analgesic treatment that starts before surgical incision to prevent central sensitization caused by incisional and inflammatory injuries.However, studies in animal models of incisional pain demonstrated that single analgesic treatment before the incision does not reduce postoperative pain. Once nociceptive afferent block subsides, the wound reinitiates central sensitization. Also, clinical trials reported similar results.Multimodal analgesia uses a combination of delivery routes administered at variable time points to optimize outcomes in the treatment of acute pain.
Therefore, in this pilot study, the investigators are trying to evaluate safety and efficacy of preemptive multimodal analgesia compared with preemptive caudal analgesia and PCA morphine in pediatric cancer patient undergoing major abdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Morphine | Active Comparator | Morphine Group C (n=30) was the control group who received IV morphine in a dose of 0.1 mg/kg after induction of anesthesia |
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| Procedure/surgery:Caudal levobupivacaine | Active Comparator | In Caudal Group (n=30), patients were placed in the lateral position and received caudal epidural block after induction of anesthesia with levobupivacaine 0.125% , 1.1 ml/kg and morphine 0.02 mg/kg with maximum 20ml. |
|
| Drug: Paracetamol and ketamine | Active Comparator | The patients of Multimodal Group (n=30) received paracetamol infusion 10 mg/kg over 10 minutes and ketamine 0.5 mg/kg IV bolus followed by ketorolac 1 mg/kg infusion over 10 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol and ketamine | Drug | intravenous paracetamol and ketamine followed by ketorolac |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption | Total morphine consumption during the postoperative 24 hours | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in VAS score for pain | it is a scoring system from 0 to 100 where 0 means no pain while 100 represents maximum pain. | Baseline and 6,12,18 and 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ehab H Shaker, MD | National Cancer Institute- Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia and Pain medicine.National Cancer Institute | Cairo | 11796 | Egypt |
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| Label | URL |
|---|---|
| Preventing chronic pain following acute pain: Risk factors, preventive strategies, and their efficacy | View source |
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after submission of the study it will be available for all researchers through the publication
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007649 | Ketamine |
| D003131 | Combined Modality Therapy |
| D007268 | Injections, Epidural |
| D009020 | Morphine |
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Caudal levobupivacaine | Procedure | an epidural injection of morphine and levobupivacaine through the caudal space |
|
|
| Morphine | Drug | patient controlled analgesia by morphine |
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013812 | Therapeutics |
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |