Preemptive Dexamethasone , Paracetamol on Postoperative Period Following Adeno-tonsillectomy in Pediatric .
Study Details
Study Description
Brief Summary
Tonsillectomy is one of the most common surgical operations performed on children, and it is frequently linked with an increased risk of complications such as acute discomfort when swallowing and postoperative nausea and vomiting (PONV).The most prevalent causes for postponing discharge home are poorly managed pain and PONV.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
Tonsillectomy is one of the most common surgical operations performed on children, and it is frequently linked with an increased risk of complications such as acute discomfort when swallowing and postoperative nausea and vomiting (PONV). The most prevalent causes for postponing discharge home are poorly managed pain and PONV. As a result, these occurrences should be avoided and managed utilizing a multimodal strategy Because of its low cost and adequate safety profile in the treatment of post-tonsillectomy pain, acetaminophen is presently regarded the fundamental analgesic in this situation. Furthermore, acetaminophen has been recommended for use in children, and its pharmacological safety in this age group has been shown. Dexamethasone is another medication that is used to reduce postoperative pain and PONV in various procedures.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: group (A) will receive intravenous paracetamol 30mg/kg (max 90 mg/kg/day). |
Drug: paracetamol
patients will receive intravenous paracetamol 30mg/kg (max 90 mg/kg/day)
|
Active Comparator: group (B) will receive dexamethasone 0.5mg/kg IV. |
Drug: Dexamethasone
patients will receive dexamethasone 0.5mg/kg IV.
|
Placebo Comparator: group(C) will received placebo 10 ml normal saline IV. |
Drug: normal Saline
patients will receive placebo 10 ml normal saline IV.
|
Outcome Measures
Primary Outcome Measures
- Total opioid consumption at PACU [two hours postoperatively]
total amount of opioid that will be taken by the patients postoperatively.
Secondary Outcome Measures
- objective pain score [at 0 minute , 30 minutes ,1 hour and 2 hours at PACU]
pain score will be assessed by 4 points pain scale 0=no pain 1 = mild pain 2= moderate pain 3=severe pain
Eligibility Criteria
Criteria
Inclusion Criteria:
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children aged between 3 and 16 years.
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All patients are ASA physical status I or II scheduled to undergo a tonsillectomy with or without adenoidectomy using sharp dissection technique.
Exclusion Criteria:
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psychiatric illness.
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cardiac disease.
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renal or hepatic impairment.
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allergy dexamethasone , paracetamol and opioids.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Banha Faculity of Medicine | Banha | Elqalyoubea | Egypt | 13511 |
Sponsors and Collaborators
- Benha University
Investigators
- Principal Investigator: fatma ahmed abdelfatah, MD, Benha University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3-10-2021