A Phase 3 interventional study of Gabapentin as premedication and placebo in Post Operative Nausea and Vomiting (PONV) and Adenotonsillectomy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2015-12-23.
Sponsored by Cairo University · Phase 3, Interventional, and Supportive care
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.
1,123 studies on the registry are indexed under Vomiting; 137 are open to participants now.
This study's enrollment of 140 is above the median of 105 across 954 interventional studies indexed under Vomiting.
Browse Vomiting studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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
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
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
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.
Incidence of PONV
The number of patient complaints of nausea and or vomiting will be recorded in the first 6 hours postoperatively
Time frame: over the first postoperative 6 hours
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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: over the first postoperative 6 hours
Postoperative analgesic consumption
Time frame: 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.
Time frame: over the first postoperative 6 hours
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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