NCT01244126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

March 3, 2016

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

3 years

First QC Date

September 16, 2010

Results QC Date

August 9, 2013

Last Update Submit

February 3, 2016

Conditions

Otitis Media

Keywords

otitis mediarecurrent ear infections (otitis media)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Maximum PAED Score

    Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge

Study Arms (3)

IM morphine

ACTIVE COMPARATOR

0.1 mg/kg morphine IM

Drug: morphine IM

IV morphine

ACTIVE COMPARATOR

0.1 mg/kg morphine IV

Drug: IV morphine

fentanyl IN

ACTIVE COMPARATOR

Intranasal fentanyl 2 mcg/kg IN

Drug: Intranasal fentanyl

Interventions

Intranasal fentanylDRUG

2mcg/kg fentanyl IN

fentanyl IN
morphine IMDRUG

0.1 mg/kg morphine IM for postop pain

IM morphine
IV morphineDRUG

0.1 mg/kg morphine IV

IV morphine

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • bilateral myringotomy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 22669347RESULT

MeSH Terms

Conditions

Otitis MediaOtitis

Interventions

Morphine

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Helena Karlberg Hippard
Organization
Baylor College of Medicine, Department of Anesthesiology
hxkarlbe@texaschildrens.org; karlberg@bcm.edu
832-824-5800

Study Officials

  • Helena Karlberg, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Department of Pediatrics and Anesthesiology Texas Children's Hospital Baylor College of Medicine

Study Record Dates

First Submitted

September 16, 2010

First Posted

November 19, 2010

Study Start

May 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 3, 2016

Results First Posted

March 3, 2016

Record last verified: 2016-02

Locations

US(1)