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| ID | Type | Description | Link |
|---|---|---|---|
| Istanbul Medipol University | Registry Identifier | Istanbul Medipol University |
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| Name | Class |
|---|---|
| Istanbul Medipol University Hospital | OTHER |
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This study is designed to compare the effectiveness of two medications, ketamine and fentanyl, in managing pain and preventing delirium in children aged 3 to 8 years who are undergoing tonsillectomy and adenoidectomy surgery. The study aims to determine which medication is better at reducing pain and preventing delirium after surgery, and which one results in faster recovery times and fewer side effects. Children participating in the study will be randomly assigned to receive either ketamine or fentanyl during their surgery. The study will measure pain levels, recovery times, and any side effects experienced by the children. The results of this study will help doctors and anesthesiologists make better decisions about which medication to use for pain management in children undergoing tonsillectomy and adenoidectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Ketamine group) | Active Comparator | The patients in this group will have intravenous ketamine (0.5 mg/kg) during induction |
|
| Group II (Fentanyl Group) | Experimental | The patients in this group will have intravenous fentanyl (1 µg/kg) during induction |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine | Drug | Induction: Sevoflurane in N2O/O2, Propofol (1-1.5 mg/kg) Analgesia: Ketamine (0.5 mg/kg) Maintenance: Sevoflurane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Face, Legs, Activity, Cry, Consolability (FLACC) Scale Range: 0 to 10 Higher scores indicate worse pain 0 = no pain, 10 = worst possible pain (Assessment of Behavioural Score: ; 0 = Relaxed and comfortable ; 1-3 = Mild discomfort ; 4-6 = Moderate pain ; 7-10 = Severe discomfort/pain.) | From the enrollment to 8 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy | Pediatric Anesthesia Emergence Delirium (PAED) Scale Range: 0 to 20 Higher scores indicate more severe emergence delirium 0 = no delirium, 20 = extreme delirium | From the enrollment to 8 hours post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medipol Mega University Hospital | Istanbul | Bagcılar | 34214 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24348289 | Background | Abdelhalim AA, Alarfaj AM. The effect of ketamine versus fentanyl on the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients undergoing tonsillectomy with or without adenoidectomy. Saudi J Anaesth. 2013 Oct;7(4):392-8. doi: 10.4103/1658-354X.121047. | |
| 27688125 | Background | Michelet D, Hilly J, Skhiri A, Abdat R, Diallo T, Brasher C, Dahmani S. Opioid-Sparing Effect of Ketamine in Children: A Meta-Analysis and Trial Sequential Analysis of Published Studies. Paediatr Drugs. 2016 Dec;18(6):421-433. doi: 10.1007/s40272-016-0196-y. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| fentanyl | Drug | Induction: Sevoflurane in N2O/O2 Analgesia: Propofol (1-1.5 mg/kg), Fentanyl (1 µg/kg) Maintenance: Sevoflurane |
|
| 24180163 | Background | Eghbal MH, Taregh S, Amin A, Sahmeddini MA. Ketamine improves postoperative pain and emergence agitation following adenotonsillectomy in children. A randomized clinical trial. Middle East J Anaesthesiol. 2013 Jun;22(2):155-60. |
| 33239908 | Background | Alghamdi F, Roth C, Jatana KR, Elmaraghy CA, Rice J, Tobias JD, Thung AK. Opioid-Sparing Anesthetic Technique for Pediatric Patients Undergoing Adenoidectomy: A Pilot Study. J Pain Res. 2020 Nov 19;13:2997-3004. doi: 10.2147/JPR.S281275. eCollection 2020. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |