Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the difference in effect of three clinically common
      methods of providing pain medication during surgery for ventilating tubes placed for
      recurring ear infections.The methods are fentanyl dripped in the nose, morphine injected in a
      muscle, and morphine injected in a vein.
    

Detailed description: 
      Preoperative anxiety will be assessed by the modified Yale Preoperative Anxiety Scale (mYPAS)
      at two points - (1) prior to separating the patient from the caretaker and bringing the
      patient to the operating room and (2) on application of the facemask. In keeping with our
      current standard practice, the child will be brought to the OR without premedication, and
      anesthesia will be induced and maintained by having the child breath sevoflurane titrated up
      to 8 %, nitrous oxide 70 % and oxygen 30 % via a facemask. In keeping with the guidelines of
      the American Society of Anesthesiologists recommendations, standard monitoring of EKG, pulse
      oxymetry, blood pressure and skin temperature will be performed. After a satisfactory level
      of anesthesia has been achieved, intravenous access will be established. All patients will
      receive intranasal, IM and IV medications as assigned by a computer generated random number
      scheme.Group A -Intranasal Fentanyl 2 mcg/kg (0.04 ml/kg), Normal saline placebo IM and IV:
      Group B Intranasal normal saline (0.01 ml/kg) placebo, Morphine 0.1 mg/kg (0.01 ml/kg)IM and
      IV normal saline placebo (0.01 ml/kg); Group C- Intranasal Placebo - normal saline 0.04
      ml/kg, IM normal saline Placebo 0.01 ml/kg and Morphine 0.1 mg/kg (0.01 ml/kg) IV.

      The surgeon will be asked to describe the condition of the middle ear (worst side) on a scale
      of 1-4 as described by Davis et al. (1 = no fluid; 2 = serous fluid; 3 = pus; and 4 = thick
      tenacious mucus-glue ear). The surgeon will also report any laceration of the ear canal.

      Induction time, surgery start and end time and arrival in PACU time will be recorded. In the
      postoperative care unit the pain score will be measured by the FLACC's pain scale (Face,
      Legs, Activity, Cry, Consolability), adverse emergence behavior will be measured by PAED
      scale described by Sikich et. al. (Pediatric Anesthesia Emergence Delirium Scale). Patients
      with pain scores greater than 4 will receive morphine 0.05 mg/kg IV, to be repeated once if
      the pain score remains greater than 4 after 10 minutes. Acetaminophen 10-15 mg/kg will be
      administered enterally for pain scores between 1-3.

      The incidence of oxygen desaturation (pulse oximetry values less than 95% for greater than 30
      secs), emesis and need for pain rescue medication will be recorded. The times of arrival in
      PACU, eye opening, response to command, ambulation, discharge readiness, and actual discharge
      home will be recorded as well. Parental satisfaction with postoperative pain control and the
      overall experience will be measured on a 10-point (0= completely dissatisfied -10= completely
      satisfied) verbal rating scale. A postoperative survey will be conducted over the phone the
      following day. Time and dose of postoperative medications, quality and duration of sleep,
      appetite and incidence of nausea and vomiting, time patient returned to presurgical level of
      playing and normal behavior and parent satisfaction will be recorded.
    

Intervention name(s): Intranasal fentanyl; morphine IM; IV morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2mcg/kg fentanyl IN; 0.1 mg/kg morphine IM for postop pain; 0.1 mg/kg morphine IV
Intervention MeSH terms: Fentanyl; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: otitis media; recurrent ear infections (otitis media)