Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Oral Gabapentin Premedication on Postoperative Nausea and Vomiting and Early Postoperative Recovery Profile in Pediatric Patients Undergoing Adenotonsillectomy

Conditions
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Post Operative Nausea and Vomiting (PONV), Adenotonsillectomy

Intervention / Treatment
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* Drug: Gabapentin as premedication
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged (3-12) ASA physical status I or II Scheduled for adenotonsillectomy surgery in Abu Elrish Al-Mounira Hospital Exclusion Criteria: Patients who have active infection Obstructive sleep apnea Cognitive impairment Abnormal bleeding profile Renal or hepatic dysfunction History of allergic reaction to study medications or chronic use of anti-consultants will be excluded.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group C<br>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. | Drug: placebo<br>* 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.<br>|
| Experimental: Group GAB<br>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 | Drug: Gabapentin as premedication<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gabapentin, PONV, Adenotonsillectomy, Pediatrics