Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

Phase 3

Completed

• Conditions: Post Operative Nausea and Vomiting (PONV); Adenotonsillectomy
• Interventions: Drug: Gabapentin as premedication; Drug: placebo

• Registration Number: NCT02384187
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Primary Completion: 2015-05
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-22
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group GAB	Gabapentin as premedication	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
Group C	placebo	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.

Primary Outcome Measures

Name	Time	Method
Incidence of PONV	over the first postoperative 6 hours	The number of patient complaints of nausea and or vomiting will be recorded in the first 6 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Time to first request of postoperative rescue analgesics.	over the first postoperative 6 hours	the time interval between the end of surgery and the first request to postoperative analgesia
Duration of recovery	up to 60 minutes after the end of surgery.	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.
Postoperative analgesic consumption	over the first postoperative 6 hours
Objective pain scale (OPS)	over the first postoperative 6 hours	The objective pain scale will be assessed at 30 minutes, 2, 4 and 6 hours postoperatively.
Pediatric Anesthesia Behavior score (PAB)	within10 minutes before the child falls asleep.	the score will be assessed during induction of anesthesia. The child will be scored 1 if Happy; 2 if Sad; and 3 if Mad.
Incidence and severity of postoperative delirium	up to 60 minutes after the end of the operation.	Emergence agitation scores will be recorded every10 min for the first 60 minutes postoperatively

Trial Locations

Locations (1)

Kasr Al Ainy; 🇪🇬 Cairo, Egypt