Efficacy of Peritonsillar Dexmedetomidine Infiltration for Postadenotonsillectomy Pain
Condition: Pain Postoperative, Intraoperative Hemorrhage
MeSH terms: Hemorrhage; Pain, Postoperative; Blood Loss, Surgical
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): 2µg/kg dexmedetomidine in 2 ml normal saline (1 ml per tonsil),
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: postoperative pain; dexmedetomidine; adenotonsillectomy