Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy
Status: | Completed |
---|---|
Conditions: | Other Indications, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases, Other |
Healthy: | No |
Age Range: | Any - 6 |
Updated: | 4/21/2016 |
Start Date: | May 2008 |
End Date: | May 2011 |
Postoperative Analgesic and Behavioral Effects of Intranasal Fentanyl, Intravenous Morphine and Intramuscular Morphine in Pediatric Patients Undergoing Bilateral Myringotomy and Placement of Ventilating Tubes
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.
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.
(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.
Inclusion Criteria:
- bilateral myringotomy
Exclusion Criteria:
- ASA greater than 2
- history of bleeding disorder/thrombocytopenia
- history of allergy to morphine or fentanyl
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