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Otitis MediaPhase 4NCT01244126

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

A Phase 4 study testing Intranasal fentanyl, morphine IM and IV morphine in people with Otitis Media, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 6 years
Conditions the study is for
Otitis Media
What is being tested?
Intranasal fentanyl, morphine IM and IV morphine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
1 siteUnited States
Study dates
May 2008to May 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • bilateral myringotomy

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Texas Children's Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
Intranasal fentanyl, morphine IM, IV morphine
Keywords
otitis media, recurrent ear infections (otitis media)
Medical subject headings
Otitis Media, Otitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intranasal fentanylDrug

    2mcg/kg fentanyl IN

  • morphine IMDrug

    0.1 mg/kg morphine IM for postop pain

  • IV morphineDrug

    0.1 mg/kg morphine IV

Study groups in NCT01244126
Study groupRoleWhat they receive
IM morphineActive comparator0.1 mg/kg morphine IM
Receives: Drug: morphine IM
IV morphineActive comparator0.1 mg/kg morphine IV
Receives: Drug: IV morphine
fentanyl INActive comparatorIntranasal fentanyl 2 mcg/kg IN
Receives: Drug: Intranasal fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (1)
  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2010 (estimated)
  2. Study startMay 2008
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01244126
Sponsor's protocol ID
H-21839
Status last verified
Feb 2016
First submitted
16 Sep 2010
Last updated
3 Mar 2016
Data monitoring committee
No

Publications

  • 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.

    PubMed 22669347

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intranasal fentanyl, morphine IM and IV morphine in people with Otitis Media, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score. (time frame: Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01244126, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.

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