Post Tonsillectomy Pain Clinical Trial
Official title:
A Comparative Study With Pre-Emptive Parenteral Oxycodone, Morphine and Dexamethasone in the Treatment of Postoperative Pain in Paediatric Patients 4 to 12 Years of Age
The aim of this randomized, double-blind study is to compare parenteral pre-emptive oxycodone, morphine and dexamethasone with placebo in the treatment of postoperative pain in paediatric patients 4 to 12 years of age. The investigators hope to find out whether there are any differences in postoperative pain and/or adverse effects among these groups.
After the induction of anaesthesia and before intubation the child receives one of the
research drugs in a double-blind fashion: 0.1 mg/kg of oxycodone , 0.1 mg/kg of morphine,
0.5 mg/kg dexamethasone (max 24 mg), or placebo. All the research drugs are diluted into a
dose of 10 ml with NaCl 0.9%, the placebo being solely the dilute.
The patients are followed minimum 4h postoperatively: first in the recovery room, and after
the patient is stable enough the study is continued in the day-patient unit. Level of pain
and adverse effects are registered all on same predetermined intervals being 15 min during
the first postoperative hour, followed by interval of 30 min until the discharge.
The safety measurements noted include pulse, respiratory rate, non-invasive blood pressure
and peripheral oxygen saturation are recorded on the same intervals The registering of pain,
adverse effects and given medication continues at home for 48 hours post operatively with a
questionnaire filled by the parents.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05109416 -
Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT00452738 -
The Effect of Pre Surgery Dog Visits on Post Surgery Consumption of Pain Medication
|
N/A |