The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
Keywords
Abstract
Dates
Last Verified: | 04/30/2013 |
First Submitted: | 08/31/2010 |
Estimated Enrollment Submitted: | 09/08/2010 |
First Posted: | 09/09/2010 |
Last Update Submitted: | 05/05/2013 |
Last Update Posted: | 05/06/2013 |
Actual Study Start Date: | 06/30/2010 |
Estimated Primary Completion Date: | 10/31/2013 |
Estimated Study Completion Date: | 11/30/2013 |
Condition or disease
Intervention/treatment
Drug: saline
Drug: ketamine
Drug: dexamethasone
Drug: dexamethasone-ketamine
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Placebo Comparator: saline 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). | Drug: saline local peritonsillar infiltration of 2 ml saline, |
Active Comparator: ketamine 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). | Drug: ketamine local peritonsillar infiltration of ketamine (0.5 mg/kg) |
Active Comparator: dexamethasone 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). | Drug: dexamethasone local peritonsillar infiltration dexamethasone (0.2 mg/kg)) |
Active Comparator: dexamethasone-ketamine 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). | Drug: dexamethasone-ketamine local peritonsillar infiltration combination of ketamine0.5mg/kg-dexamethason 0.2mg/kg |
Eligibility Criteria
Ages Eligible for Study | 3 Years To 3 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: - 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, - |
Outcome
Primary Outcome Measures
1. pain will be assessed by [observational pain scores (OPS)] [5 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU)]
2. 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))]
3. 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))]
4. 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))]
5. 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))]
6. postoperative analgesic consumption [during 24 h postoperative (in the ward)]
Secondary Outcome Measures
1. nausea, vomiting will be assessed by questioning their parents. [during 60th min after extubation at postanesthesia care unit]
2. bleeding will be assessed by questioning their parents [during 24 h postoperative (in the ward)]
3. family satisfaction will be assessed by questioning their parents. [during 24 h postoperative (in the ward).]
4. nausea, vomiting will be assessed by questioning their parents. [during 24 h postoperative (in the ward)]