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The frequent incidence of postoperative vomiting and severe pain in children undergoing adenotonsillectomy, may delay postoperative oral intake and increase the risk of dehydration. Postoperative nausea and vomiting (PONV) is of multi-factorial origin in this group of patients, with a reported incidence ranging from 23% to 73%.
There is growing evidence that the perioperative administration of gabapentinin in adults is beneficial for preoperative anxiolysis, postoperative analgesia, reduction of postoperative nausea and vomiting, and delirium.
Only few studies in literature explored the analgesic effects of preoperative gabapentin as premedication in pediatric population. However, the antiemetic effect of gabapentin in pediatric patients was not systematically investigated before.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C | Placebo Comparator | Patients in this group will receive 0.3 ml/kg of a placebo solution identical in taste, shape and color to the study medication two hours before the induction of anesthesia. |
|
| Group GAB | Experimental | Patients in this group will receive 0.3 ml/kg (16 mg/kg) oral gabapentin solution (Neurontin 50 mg/ml, Pfizer Pharmaceutical) as premedication two hours before the induction of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin as premedication | Drug | Patients will receive 0.3 ml/kg (16 mg/kg) oral gabapentin solution (Neurontin 50 mg/ml, Pfizer Pharmaceutical) as premedication two hours before the induction of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of PONV | The number of patient complaints of nausea and or vomiting will be recorded in the first 6 hours postoperatively | over the first postoperative 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Anesthesia Behavior score (PAB) | the score will be assessed during induction of anesthesia. The child will be scored 1 if Happy; 2 if Sad; and 3 if Mad. | within10 minutes before the child falls asleep. |
| Incidence and severity of postoperative delirium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Abdulatif, Professor of Anesthesia | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al Ainy | Cairo | 11562 | Egypt |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D011292 | Premedication |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| placebo | Drug | Patients will receive 0.3 ml/kg of a placebo solution identical in taste, shape and color to the study medication two hours before the induction of anesthesia. |
|
Emergence agitation scores will be recorded every10 min for the first 60 minutes postoperatively |
| up to 60 minutes after the end of the operation. |
| Duration of recovery | The extubation time will be the time interval from discontinuation of sevoflurane until removal of the endotracheal tube. The time to interaction will be the time from discontinuation of sevoflurane until verbal contact or response to commands. | up to 60 minutes after the end of surgery. |
| Time to first request of postoperative rescue analgesics. | the time interval between the end of surgery and the first request to postoperative analgesia | over the first postoperative 6 hours |
| Postoperative analgesic consumption | over the first postoperative 6 hours |
| Objective pain scale (OPS) | The objective pain scale will be assessed at 30 minutes, 2, 4 and 6 hours postoperatively. | over the first postoperative 6 hours |
| D010335 | Pathologic Processes |
| D009325 | Nausea |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |