The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
Brief Summary
Intervention / Treatment
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Saline (DRUG)local peritonsillar infiltration of 2 ml saline,
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Ketamine (DRUG)local peritonsillar infiltration of ketamine (0.5 mg/kg)
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Dexamethasone (DRUG)local peritonsillar infiltration dexamethasone (0.2 mg/kg))
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ketamine-dexamethasone (DRUG)local peritonsillar infiltration combination of ketamine0.5mg/kg-dexamethason 0.2mg/kg
Condition or Disease
- Tonsillectomy
Phase
Study Design
Study type: | INTERVENTIONAL |
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Status: | Unknown status |
Study results: | No Results Available |
Age: | 3 Years to 12 Years |
Enrollment: | 160 (ESTIMATED) |
Funded by: | Other |
Allocation: | Randomized |
Primary Purpose: | Prevention |
MaskingQUADRUPLE:
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Clinical Trial Dates
Start date: | Jul 01, 2010 | |
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Primary Completion: | Nov 01, 2013 | ESTIMATED |
Completion Date: | Dec 01, 2013 | ESTIMATED |
Study First Posted: | Sep 10, 2010 | ESTIMATED |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | May 06, 2013 |
Sponsors / Collaborators
Location
Participant Groups
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One hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups).
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One hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups).
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One hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups).
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One hundred sixtyAmerican Society of Anesthesiologists (ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups).
Eligibility Criteria
Sex: | All |
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Minimum Age: | 3 |
Maximum Age: | 12 |
Age Groups: | Child |
Healthy Volunteers: | Yes |
* children age 3-12 years ASAI,II
Exclusion Criteria:
* contraindication for usage of Ketamine, dexamethasone
* upper respiratory tract infection
* increase intracranial pressure( ICP)
* history of allergy ,seizure,psychiatric illness, , bleeding disorders
* chronic usage of analgesic ,antiemetic ,stroied drugs two weeks before surgery,
* history of peritonsillar abscess, , tonsillitis within two weeks, -
Primary Outcomes
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pain will be assessed by [observational pain scores (OPS)] 5 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU)
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pain will be assessed by [observational pain scores (OPS)] 15th min postoperatively (15 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
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pain will be assessed by [observational pain scores (OPS)] 30th min postoperatively (30 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
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pain will be assessed by [observational pain scores (OPS)] 60thmin postoperatively (60 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
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time to first demand of analgesia during 60min postoperatively (during 60 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
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postoperative analgesic consumption during 24 h postoperative (in the ward)
Secondary Outcomes
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nausea, vomiting will be assessed by questioning their parents. during 60th min after extubation at postanesthesia care unit
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bleeding will be assessed by questioning their parents during 24 h postoperative (in the ward)
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family satisfaction will be assessed by questioning their parents. during 24 h postoperative (in the ward).
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nausea, vomiting will be assessed by questioning their parents. during 24 h postoperative (in the ward)
More Details
NCT Number: | NCT01198210 |
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Other IDs: | ACTRN12610000658011 |
Study URL: | https://clinicaltrials.gov/study/NCT01198210 |