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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helena Karlberg, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01244126
First received: September 16, 2010
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Otitis Media
Drug: IN fentanyl
Drug: morphine IM
Drug: IV morphine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Post-operative pain control [ Time Frame: post-anesthesia care,60 minutes ] [ Designated as safety issue: Yes ]
    Patients are evaluated for pain control in the post-anesthesia care unit upon arrival and at 5,10,15,30 45 and 60 minutes and when at home within the next 24 hours following surgery.


Secondary Outcome Measures:
  • time to discharge [ Time Frame: post anesthesia care unit time, 60 minutes ] [ Designated as safety issue: Yes ]
    We will also study which method will enable the fastest discharge home from the recovery room and has the least amount of side effects.


Enrollment: 171
Study Start Date: May 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IM morphine
0.1 mg/kg morphine IM
Drug: IN fentanyl
2mcg/kg fentanyl IN
Active Comparator: IV morphine
0.1 mg/kg morphine IV
Drug: IN fentanyl
2mcg/kg fentanyl IN
Drug: morphine IM
0.1 mg/kg morphine IM for postop pain
Active Comparator: fentanyl
2 mcg/kg fentanyl IN
Drug: morphine IM
0.1 mg/kg morphine IM for postop pain
Drug: IV morphine
0.1 mg/kg morphine IV

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bilateral myringotomy

Exclusion Criteria:

  • ASA greater than 2
  • history of bleeding disorder/thrombocytopenia
  • history of allergy to morphine or fentanyl
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244126

Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Helena Karlberg, MD Baylor College of Medicine
  More Information

No publications provided by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helena Karlberg, Associate Professor Department of Pediatrics and Anesthesiology Texas Children's Hospital Baylor College of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01244126     History of Changes
Other Study ID Numbers: H-21839
Study First Received: September 16, 2010
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
otitis media
recurrent ear infections (otitis media)

Additional relevant MeSH terms:
Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Morphine
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014