Adenotonsillectomy, Post Operative Nausea and Vomiting (PONV)
Conditions
Keywords
Gabapentin, PONV, Adenotonsillectomy, Pediatrics
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.
Interventions
DRUGGabapentin 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
DRUGplacebo
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PONV | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of postoperative delirium | up to 60 minutes after the end of the operation. | Emergence agitation scores will be recorded every10 min for the first 60 minutes postoperatively |
| Objective pain scale (OPS) | over the first postoperative 6 hours | The objective pain scale will be assessed at 30 minutes, 2, 4 and 6 hours postoperatively. |
| Pediatric Anesthesia Behavior score (PAB) | 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. |
| Time to first request of postoperative rescue analgesics. | over the first postoperative 6 hours | the time interval between the end of surgery and the first request to postoperative analgesia |
| Postoperative analgesic consumption | over the first postoperative 6 hours | — |
| Duration of recovery | 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. |
Countries
Egypt
Outcome results
None listed