Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Adenotonsillectomy; Post Operative Nausea and Vomiting (PONV)

Treatments: Drug: Gabapentin as premedication; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02384187

N-47-2014

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Group C

Placebo Comparator group

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.

Treatment:

Drug: placebo

Group GAB

Experimental group

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

Treatment:

Drug: Gabapentin as premedication