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Completed

NCT Number: NCT02384187

Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

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.

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Key information

Conditions

Post Operative Nausea and Vomiting (PONV) Adenotonsillectomy Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Al Ainy

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin as premedication

Drug

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

Drug

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 outcomes

  1. Incidence of PONV

    Time frame: 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 outcomes

  1. Pediatric Anesthesia Behavior score (PAB)

    Time frame: 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.

  2. Incidence and severity of postoperative delirium

    Time frame: up to 60 minutes after the end of the operation.

    Emergence agitation scores will be recorded every10 min for the first 60 minutes postoperatively

  3. Duration of recovery

    Time frame: 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.

  4. Time to first request of postoperative rescue analgesics.

    Time frame: over the first postoperative 6 hours

    the time interval between the end of surgery and the first request to postoperative analgesia

  5. Postoperative analgesic consumption

    Time frame: over the first postoperative 6 hours

  6. Objective pain scale (OPS)

    Time frame: over the first postoperative 6 hours

    The objective pain scale will be assessed at 30 minutes, 2, 4 and 6 hours postoperatively.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 10, 2015
Registry last updated
Dec 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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