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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IM morphine | Active Comparator | 0.1 mg/kg morphine IM |
|
| IV morphine | Active Comparator | 0.1 mg/kg morphine IV |
|
| fentanyl IN | Active Comparator | Intranasal fentanyl 2 mcg/kg IN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal fentanyl | Drug | 2mcg/kg fentanyl IN |
| |
| morphine IM |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena Karlberg, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22669347 | Result | Hippard HK, Govindan K, Friedman EM, Sulek M, Giannoni C, Larrier D, Minard CG, Watcha MF. Postoperative analgesic and behavioral effects of intranasal fentanyl, intravenous morphine, and intramuscular morphine in pediatric patients undergoing bilateral myringotomy and placement of ventilating tubes. Anesth Analg. 2012 Aug;115(2):356-63. doi: 10.1213/ANE.0b013e31825afef3. Epub 2012 Jun 5. |
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1531 children screened, 1143 excluded as not qualifying, 217 declined to participate
Children scheduled for bilateral myringotomy and insertion of tubes at TCH from September 2008 to Feb 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | IM Morphine | 0.1 mg/kg morphine IM |
| FG001 | IV Morphine | 0.1 mg/kg morphine IV |
| FG002 | Fentanyl IN | Intranasal fentanyl 2 mcg/kg IN |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IM Morphine | 0.1 mg/kg morphine IM |
| BG001 | IV Morphine | 0.1 mg/kg morphine IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Analysis was performed on per protocol basis excluding patients with protocol violations | Posted | Mean | Standard Deviation | units on a scale | Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IM Morphine | 0.1 mg/kg morphine IM |
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This study used an objective pain scale where the minimum clinically important difference in scores is unknown. The study did not use a group receiving no active treatment as this was unethical. We also did not measure blood levels of opioids.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helena Karlberg Hippard | Baylor College of Medicine, Department of Anesthesiology | 832-824-5800 | hxkarlbe@texaschildrens.org; karlberg@bcm.edu |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Drug |
0.1 mg/kg morphine IM for postop pain |
|
| IV morphine | Drug | 0.1 mg/kg morphine IV |
|
| BG002 |
| Fentanyl IN |
Intranasal fentanyl 2 mcg/kg IN |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Limited to patients who completed study | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight in Kgs | Excluded 15 patients for protocol violations. These 15 patients did not undergo study procedures Baseline measures only of completed cases | Mean | Standard Deviation | Kgs |
|
| Number completing study | 15 cases excluded for protocol violations including 3, 3 and 9 in the IM morphine, IV morphine and IN fentanyl groups respectively. | Number | participants |
|
| Gender in patients completing study | Excluding protocol violations | Number | Participants |
|
| ASA Physical Status in Patients who completed study | Limited to those who completed study and excluding protocol violations ASA PHYSICAL STATUS CLASSIFICATION SYSTEM Last approved by the ASA House of Delegates on October 15, 2014 Definition ASA I A normal healthy patient Healthy, non-smoking, no or minimal alcohol use ASA II A patient with mild systemic disease Mild diseases only without substantive functional limitations. | Number | Participants |
|
| OG002 | Fentanyl IN | Intranasal fentanyl 2 mcg/kg IN |
|
|
|
| Secondary | 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. | The sample size was based on the assumption that the pain scores in the intranasal fentanyl group would be similar to those in previously published data | Posted | Mean | Standard Deviation | units on a scale | Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge |
|
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Fentanyl IN | Intranasal fentanyl 2 mcg/kg IN | 0 | 53 | 0 | 53 |
| EG002 | IV Morphine | 0.1 mg/kg morphine IV | 0 | 53 | 0 | 53 |
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |