Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Adenotonsillectomy; Post Operative Nausea and Vomiting (PONV)
• Intervention / Treatment: Drug: placebo; Drug: Gabapentin as premedication

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Kasr Al Ainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group C; 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 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.
Experimental: Group GAB; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Mohamed Abdulatif, Professor of Anesthesia, Cairo University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 10, 2015

Study Record Updates

• Last Update Posted (Estimate): December 23, 2015
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Pediatrics; Gabapentin; PONV; Adenotonsillectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: N-47-2014