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Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

Primary Purpose

Post Operative Nausea and Vomiting (PONV), Adenotonsillectomy

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Gabapentin as premedication
placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Operative Nausea and Vomiting (PONV) focused on measuring Gabapentin, PONV, Adenotonsillectomy, Pediatrics

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kasr Al Ainy

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Group C

Group GAB

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Incidence and severity of postoperative delirium
Emergence agitation scores will be recorded every10 min for the first 60 minutes postoperatively
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 to first request of postoperative rescue analgesics.
the time interval between the end of surgery and the first request to postoperative analgesia
Postoperative analgesic consumption
Objective pain scale (OPS)
The objective pain scale will be assessed at 30 minutes, 2, 4 and 6 hours postoperatively.

Full Information

First Posted
February 20, 2015
Last Updated
December 22, 2015
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02384187
Brief Title
Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients
Official Title
The Effects of Oral Gabapentin Premedication on Postoperative Nausea and Vomiting and Early Postoperative Recovery Profile in Pediatric Patients Undergoing Adenotonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Nausea and Vomiting (PONV), Adenotonsillectomy
Keywords
Gabapentin, PONV, Adenotonsillectomy, Pediatrics

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Group GAB
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Gabapentin as premedication
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of PONV
Description
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
Secondary Outcome Measure Information:
Title
Pediatric Anesthesia Behavior score (PAB)
Description
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.
Title
Incidence and severity of postoperative delirium
Description
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.
Title
Duration of recovery
Description
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.
Title
Time to first request of postoperative rescue analgesics.
Description
the time interval between the end of surgery and the first request to postoperative analgesia
Time Frame
over the first postoperative 6 hours
Title
Postoperative analgesic consumption
Time Frame
over the first postoperative 6 hours
Title
Objective pain scale (OPS)
Description
The objective pain scale will be assessed at 30 minutes, 2, 4 and 6 hours postoperatively.
Time Frame
over the first postoperative 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdulatif, Professor of Anesthesia
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Kasr Al Ainy
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

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Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

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