Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be a randomized double blind placebo controlled clinical trial among children undergoing adeno-tonsillectomy in KNH. The intervention arm will comprise Fentanyl given at a dose of 1ug/while the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose, treatment will be administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed. The main outcome will be incidence of ED at the recovery room using Watcha scale and secondary outcomes will be delay in emergence time from anaesthesia and effectiveness of fentanyl in preventing ED.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl group | Active Comparator | Fentanyl given at a dose of one micro gram per kilogram body weight |
|
| normal saline group | Placebo Comparator | placebo arm will be given normal saline at a volume equivalent to Fentanyl dose as per body weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | The intervention arm will comprise Fentanyl given at a dose of one microgram per kilogramme body weight administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients who develop emergence delirium in both arms | the number of patients who develop emergence delirium within 30 minutes after general anaesthesia will be assessed using Watcha scale indicated in the study questionnaire, | 30 minutes |
| the local incidence of emergence delirium. | local incidence of emergence delirium will be determined by the percentage of those who develop emergence delirium in the placebo group within 30 minutes after general anesthesia as assessed by Watcha scale. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| the percentage of patients developing emergence delirium in fentanyl group with 30 minutes after general anaesthesia. | the percentage of patients developing emergence delirium in both groups will be compared to determine if fentanyl prevents emergence delirium. | 30 minutes |
| duration of emergence time from general anaesthesia in minutes |
Not provided
Inclusion Criteria:
American Society of Anaesthesiologists classes (ASA) 1 and 2 children.
Children aged 1 to 12 years.
Children undergoing elective adeno-tonsilectomy.
Those children whose parents/guardians have given a written informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
conferences, report writing
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D013812 | Therapeutics |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Normal saline | Drug | the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose per body weight,administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed |
|
|
the time taken to emerge from both arms will be compared to determine if fentanyl delays emergence time from general anaesthesia. |
| 30 minutes |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |