Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02013570 |
| Other study ID # |
2013/556 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
December 2, 2013 |
| Last updated |
December 11, 2013 |
| Start date |
September 2013 |
| Est. completion date |
December 2013 |
Study information
| Verified date |
September 2013 |
| Source |
TC Erciyes University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the present study is the clinical assessment of the efficacy of preincisional
peritonsillar infiltration of dexmedetomidine on postoperative pain relief in children
undergoing adenotonsillectomy.
Description:
Background:Tonsillectomy is a common and painful procedure in children, often performed on an
outpatient basis. Tonsillectomy is often associated with intraoperative bleeding and
postoperative severe pain. Different methods such as drugs (nonsteroidal antiinflammatory
drugs , opioids, corticosteroids ), adjustment of surgical technique and peroperative local
anaesthetic infiltration have been used to reduce pain. It is known that pain after
adenotonsillectomy or analgesic usage may lead to unwanted effects. For example, nonsteroidal
antiinflammatory drugs may interfere with bleeding and opioids may cause respiratory
depression, sedation or nausea and vomiting. There are some reported complications seen
infiltrations of local anaesthetics into tonsillar and adenoid beds. No studies have assessed
the effects of peritonsillar dexmedetomidine infiltration. Dexmedetomidine is a centrally
acting sympatholytic agent that has intrinsic effect of regional anesthesia with amid
anesthetic.Because of its analgesic and sedating activity, dexmedetomidine has been used
previously as an nasal premedication in patients undergoing tonsillectomy, but its use, as a
peritonsillar infiltration has not been evaluated. Dexmedetomidine is a highly selective
alfa-2 adrenoreceptor agonist recently introduced to anesthesia practice producing
dose-depended sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites),
without respiratory depression. Also Alpha-2 adrenergic agonists have peripheral analgesic
effects. Therefore, this study was designed to compare the effects of preincisional,
dexmedetomidine 2µg/kg peritonsillar infiltration by peritonsillar normal saline grup on
intraoperative bleeding and hemodynamics, postoperative recovery including pain, sedation,
nausea and vomiting in pediatric patients undergoing adenotonsillectomy, and the recording of
any adverse effects that might develop during the 24-h study period.
Methods: Seventy patient were randomized into two groups: group S peritonsillar 2ml normal
saline (1 ml per tonsil), group D 2mikro gram/kg dexmedetomidine in 2 ml normal saline (1 ml
per tonsil).
After institutional Ethics Committee approval and parents written consent, 70 children aged
3-9 years, American Society of Anesthesiologists 1-2 status, scheduled for adenotonsillectomy
were enrolled in this randomized, prospective, triple-blind clinical study. Children with
systemic disease, metabolic and endocrin disorders, growth developmental and motor-mental
retardation, those who had a history of allergy to any of the study drugs, peritonsillar
abscess, hypertension, psychiatric and epileptic disorders, chronic pain syndrome, and those
who received analgesics within 24 h prior to surgery were excluded from study.
The children were unpremedicated. Anaesthesia was induced with sevoflurane 8% and nitrous
oxide 70% in oxygen or intravenous induction with propofol (2,5-3 mg/kg). After induction
rocuronium 0,6 mg/kg was administered for muscle relaxation and fentanyl 1 µg/kg before
tracheal intubation. Anaesthesia was maintained with sevoflurane 2-3% and nitrous oxide 30%
in oxygen. After intubation children were randomized into two groups:Group D 2µg/kg
dexmedetomidine in 2 ml normal saline (1 ml per tonsil), Group S peritonsillar 2ml normal
saline (1 ml per tonsil) via peritonsillar infiltration. For the infiltration, all injections
were performed through the tonsillar capsule and anterior plica. After the infiltration, a
minimum of 3 min was allowed for the onset of action of dexmedetomidine before
adenotonsillectomy. Adenotonsillectomy was performed with snare technic by the same surgeon
in all cases. Heart rate, arterial pressure and oxygen saturations (SpO2) were recorded at 10
min interval during operation.All patients received metoclopropamide 0,2 mg/kg i.v. before
end of the surgery. After extubation the patients were taken to the postanesthesia care unit
where an anesthetist and nurses who were unaware of the study drug observed the patients.
Modified Hannallah pain scale (observational pain scores-OPS), nausea, vomiting, bleeding,
rescue analgesia, sedation and Aldrete scores were recorded on arrival in the postanesthesia
care unit, at 15th, 30th, 60th, 90th and 120th min. Patient with OPS scores >4, for a patient
request for pain medication, received 1mg/kg Tramadol drop as supplementary analgesia. The
first analgesic requirement time recorded. Children vomiting twice or more in PACU received
additional antiemetic drug (metoclopropamide 0,2 mg/kg i.v.). Agitation was measured with
Pediatric anesthesia emergence delirium scale. Patients with an Aldrete score of 9 were
transferred to the postoperative surgical ward.
Pain, nausea and vomiting, bleeding and sedation were assessed in the postoperative surgical
ward at0,2,4,6h follow-up by the nurses who were trained fort he use of scores involved.
Analgesic requirement were recorded. Pain was measured at rest and with swallowing. All
patients were discharged at the and of the day and stayed home at night. Before the
discharge, parents were given a prescription for acetaminophen (15 mg/kg oral dose) to be
given when needs to analgesia. Postoperative pain during the first 24 h was assessed using a
four-point scale: 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain by questioning their
parents. Patients were interviewed on the day after surgery to asses the postoperative pain,
vomiting, bleeding and rescue analgesia. Family satisfaction was assessed as follows: 1=poor;
2=good; 3=perfect.
