Effect of Preemptive Dexamethasone and Paracetamol on Postoperative Period Following Adeno-tosillectomy in Pediatric Age Group-: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Benha University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Total opioid consumption at PACU
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 3 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •children aged between 3 and 16 years.
- •All patients are ASA physical status I or II scheduled to undergo a tonsillectomy with or without adenoidectomy using sharp dissection technique.
Exclusion Criteria
- •psychiatric illness.
- •cardiac disease.
- •renal or hepatic impairment.
- •allergy dexamethasone , paracetamol and opioids.
Arms & Interventions
group (A)
will receive intravenous paracetamol 30mg/kg (max 90 mg/kg/day).
Intervention: paracetamol (Drug)
group (B)
will receive dexamethasone 0.5mg/kg IV.
Intervention: Dexamethasone (Drug)
group(C)
will received placebo 10 ml normal saline IV.
Intervention: normal Saline (Drug)
Outcomes
Primary Outcomes
Total opioid consumption at PACU
Time Frame: two hours postoperatively
total amount of opioid that will be taken by the patients postoperatively.
Secondary Outcomes
- objective pain score(at 0 minute , 30 minutes ,1 hour and 2 hours at PACU)
Investigators
Fatma Ahmed Abdel Fatah
lecturer
Benha University