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

NCT ID: NCT01244126

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-05-31

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.

Conditions

Otitis Media

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IM morphine

0.1 mg/kg morphine IM

Group Type: ACTIVE_COMPARATOR

morphine IM

Intervention Type: DRUG

0.1 mg/kg morphine IM for postop pain

IV morphine

0.1 mg/kg morphine IV

Group Type: ACTIVE_COMPARATOR

IV morphine

Intervention Type: DRUG

0.1 mg/kg morphine IV

fentanyl IN

Intranasal fentanyl 2 mcg/kg IN

Group Type: ACTIVE_COMPARATOR

Intranasal fentanyl

Intervention Type: DRUG

2mcg/kg fentanyl IN

Interventions

Intranasal fentanyl

2mcg/kg fentanyl IN

Intervention Type: DRUG

morphine IM

0.1 mg/kg morphine IM for postop pain

Intervention Type: DRUG

IV morphine

0.1 mg/kg morphine IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• bilateral myringotomy

Exclusion Criteria

• ASA greater than 2
• history of bleeding disorder/thrombocytopenia
• history of allergy to morphine or fentanyl

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Helena Karlberg

Associate Professor Department of Pediatrics and Anesthesiology Texas Children's Hospital Baylor College of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helena Karlberg, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22669347 (View on PubMed)

Other Identifiers

H-21839

Identifier Type: -

Identifier Source: org_study_id