Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

Adenotonsillectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384187
• Other study ID #: N-47-2014
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2015
• Last updated: December 22, 2015
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adenotonsillectomy
• Post Operative Nausea and Vomiting (PONV)
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Kasr Al Ainy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	No
Secondary	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.	Yes
Secondary	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.	No
Secondary	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	No
Secondary	Postoperative analgesic consumption		over the first postoperative 6 hours	No
Secondary	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	No