Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy

Study Overview
=================
Brief 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.

Official Title
-----------------
Postoperative Analgesic and Behavioral Effects of Intranasal Fentanyl, Intravenous Morphine and Intramuscular Morphine in Pediatric Patients Undergoing Bilateral Myringotomy and Placement of Ventilating Tubes

Conditions
-----------------
Otitis Media

Intervention / Treatment
-----------------
* Drug: Intranasal fentanyl
* Drug: morphine IM
* Drug: IV morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bilateral myringotomy Exclusion Criteria: ASA greater than 2 history of bleeding disorder/thrombocytopenia history of allergy to morphine or fentanyl

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IM morphine<br>0.1 mg/kg morphine IM | Drug: morphine IM<br>* 0.1 mg/kg morphine IM for postop pain<br>|
| Active Comparator: IV morphine<br>0.1 mg/kg morphine IV | Drug: IV morphine<br>* 0.1 mg/kg morphine IV<br>|
| Active Comparator: fentanyl IN<br>Intranasal fentanyl 2 mcg/kg IN | Drug: Intranasal fentanyl<br>* 2mcg/kg fentanyl IN<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score. | FLACC assigns 0-2 points for each of 5 categories (face, legs, activity, cry, consolability)and sums these points to give a total score where high scores indicate worse pain (Paediatr Anaesth 2006; 16: 258-65) | Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum PAED Score | Maximum score on the Pediatric Anesthesia Emergence delirium scale. This has 5 items ranging from 1-4 and higher scores indicate greater emergence delirium. 1. eye contact with care giver ,score 1-4, purposeful actions 1-4, aware of surrounding 1-4,restless 1-4, inconsolable 1-4, Maximum score 20. | Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
otitis media, recurrent ear infections (otitis media)