NCT02653742

Brief Summary

The purpose of this study is to compare the efficacy and safety of ketorolac sublingual with fentanyl intranasal used in our hospital for pain control in children undergoing bilateral myringotomy with placement of pressure equalization tubes (BMTs).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

7.6 years

First QC Date

January 8, 2016

Last Update Submit

September 9, 2021

Conditions

Pain, PostoperativeOtitis Media

Outcome Measures

Primary Outcomes (1)

  • Pain score assessment

    Pain assessment score using CHEOPS

    Through study completion, an average of 1 hour postop

Secondary Outcomes (1)

  • Administration of additional pain medication

    Through study completion, an average of 1 hour postop

Study Arms (3)

Ketorolac

EXPERIMENTAL

Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use.

Drug: Ketorolac

Fentanyl

EXPERIMENTAL

Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use.

Drug: Fentanyl

Ketorolac and Fentanyl

EXPERIMENTAL

Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use and Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use.

Drug: KetorolacDrug: Fentanyl

Interventions

KetorolacDRUG

Ketorolac 1mg/kg sublingual is administered after induction of general anesthesia.

Also known as: Toradol
KetorolacKetorolac and Fentanyl
FentanylDRUG

Fentanyl 2mg/kg intranasal is administered after induction of general anesthesia

FentanylKetorolac and Fentanyl

Eligibility Criteria

Age8 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • American Society of Anesthesiologist (ASA) I-II physical class
  • Scheduled for elective BMT
  • Mask induction of anesthesia

You may not qualify if:

  • Allergy to any NSAIDs
  • Severe upper respirator infection
  • Severe asthma
  • Bleeding disorders
  • History of GI bleeding
  • Renal impairment
  • Scheduled for one-sided myringotomy and tube placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Related Publications (24)

  • Croteau N, Hai V, Pless IB, Infante-Rivard C. Trends in medical visits and surgery for otitis media among children. Am J Dis Child. 1990 May;144(5):535-8. doi: 10.1001/archpedi.1990.02150290029019.

    PMID: 2330920BACKGROUND

  • Watcha MF, Ramirez-Ruiz M, White PF, Jones MB, Lagueruela RG, Terkonda RP. Perioperative effects of oral ketorolac and acetaminophen in children undergoing bilateral myringotomy. Can J Anaesth. 1992 Sep;39(7):649-54. doi: 10.1007/BF03008224.

    PMID: 1394752BACKGROUND

  • Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.

    PMID: 5534693BACKGROUND

  • Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736.

    PMID: 19020154BACKGROUND

  • Gupta A, Daggett C, Ludwick J, Wells W, Lewis A. Ketorolac after congenital heart surgery: does it increase the risk of significant bleeding complications? Paediatr Anaesth. 2005 Feb;15(2):139-42. doi: 10.1111/j.1460-9592.2005.01409.x.

    PMID: 15675931BACKGROUND

  • Aldrink JH, Ma M, Wang W, Caniano DA, Wispe J, Puthoff T. Safety of ketorolac in surgical neonates and infants 0 to 3 months old. J Pediatr Surg. 2011 Jun;46(6):1081-5. doi: 10.1016/j.jpedsurg.2011.03.031.

    PMID: 21683202BACKGROUND

  • Papacci P, De Francisci G, Iacobucci T, Giannantonio C, De Carolis MP, Zecca E, Romagnoli C. Use of intravenous ketorolac in the neonate and premature babies. Paediatr Anaesth. 2004 Jun;14(6):487-92. doi: 10.1111/j.1460-9592.2004.01250.x.

    PMID: 15153212BACKGROUND

  • Lynn AM, Bradford H, Kantor ED, Andrew M, Vicini P, Anderson GD. Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months. Paediatr Anaesth. 2011 Mar;21(3):325-34. doi: 10.1111/j.1460-9592.2010.03484.x. Epub 2010 Dec 29.

    PMID: 21199130BACKGROUND

  • Cohen MN, Christians U, Henthorn T, Vu Tran Z, Moll V, Zuk J, Galinkin J. Pharmacokinetics of single-dose intravenous ketorolac in infants aged 2-11 months. Anesth Analg. 2011 Mar;112(3):655-60. doi: 10.1213/ANE.0b013e3182075d04. Epub 2011 Jan 13.

    PMID: 21233498BACKGROUND

  • Pappas AL, Fluder EM, Creech S, Hotaling A, Park A. Postoperative analgesia in children undergoing myringotomy and placement equalization tubes in ambulatory surgery. Anesth Analg. 2003 Jun;96(6):1621-1624. doi: 10.1213/01.ANE.0000064206.51296.1D.

    PMID: 12760984BACKGROUND

  • Zuppa AF, Mondick JT, Davis L, Cohen D. Population pharmacokinetics of ketorolac in neonates and young infants. Am J Ther. 2009 Mar-Apr;16(2):143-6. doi: 10.1097/MJT.0b013e31818071df.

    PMID: 19300040BACKGROUND

  • Neri E, Maestro A, Minen F, Montico M, Ronfani L, Zanon D, Favret A, Messi G, Barbi E. Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a double-blind, randomised, controlled trial. Arch Dis Child. 2013 Sep;98(9):721-4. doi: 10.1136/archdischild-2012-303527. Epub 2013 May 23.

    PMID: 23702435BACKGROUND

  • Gupta A, Daggett C, Drant S, Rivero N, Lewis A. Prospective randomized trial of ketorolac after congenital heart surgery. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):454-7. doi: 10.1053/j.jvca.2004.05.024.

    PMID: 15365927BACKGROUND

  • Perez-Urizar J, Aguilar-Cota ME, Herrera JE, Flores-Murrieta FJ. Comparative bioavailability of ketorolac tromethamine after intramuscular and sublingual administration. Proc West Pharmacol Soc. 2002;45:6-7. No abstract available.

    PMID: 12434509BACKGROUND

  • Drover DR, Hammer GB, Anderson BJ. The pharmacokinetics of ketorolac after single postoperative intranasal administration in adolescent patients. Anesth Analg. 2012 Jun;114(6):1270-6. doi: 10.1213/ANE.0b013e31824f92c2. Epub 2012 Mar 30.

    PMID: 22467894BACKGROUND

  • He A, Hersh EV. A review of intranasal ketorolac tromethamine for the short-term management of moderate to moderately severe pain that requires analgesia at the opioid level. Curr Med Res Opin. 2012 Dec;28(12):1873-80. doi: 10.1185/03007995.2012.744302. Epub 2012 Nov 9.

    PMID: 23098098BACKGROUND

  • Garnock-Jones KP. Intranasal ketorolac: for short-term pain management. Clin Drug Investig. 2012 Jun 1;32(6):361-71. doi: 10.2165/11209240-000000000-00000.

    PMID: 22574632BACKGROUND

  • Finkel JC, Cohen IT, Hannallah RS, Patel KM, Kim MS, Hummer KA, Choi SS, Pena M, Schreiber SB, Zalzal G. The effect of intranasal fentanyl on the emergence characteristics after sevoflurane anesthesia in children undergoing surgery for bilateral myringotomy tube placement. Anesth Analg. 2001 May;92(5):1164-8. doi: 10.1097/00000539-200105000-00016.

    PMID: 11323340BACKGROUND

  • Galinkin JL, Fazi LM, Cuy RM, Chiavacci RM, Kurth CD, Shah UK, Jacobs IN, Watcha MF. Use of intranasal fentanyl in children undergoing myringotomy and tube placement during halothane and sevoflurane anesthesia. Anesthesiology. 2000 Dec;93(6):1378-83. doi: 10.1097/00000542-200012000-00006.

    PMID: 11149429BACKGROUND

  • Karl HW, Rosenberger JL, Larach MG, Ruffle JM. Transmucosal administration of midazolam for premedication of pediatric patients. Comparison of the nasal and sublingual routes. Anesthesiology. 1993 May;78(5):885-91. doi: 10.1097/00000542-199305000-00013.

    PMID: 8489062BACKGROUND

  • Bean-Lijewski JD, Stinson JC. Acetaminophen or ketorolac for post myringotomy pain in children? A prospective, double-blinded comparison. Paediatr Anaesth. 1997;7(2):131-7. doi: 10.1046/j.1460-9592.1997.d01-47.x.

    PMID: 9188114BACKGROUND

  • Forrest JB, Heitlinger EL, Revell S. Ketorolac for postoperative pain management in children. Drug Saf. 1997 May;16(5):309-29. doi: 10.2165/00002018-199716050-00003.

    PMID: 9187531BACKGROUND

  • Davis PJ, Greenberg JA, Gendelman M, Fertal K. Recovery characteristics of sevoflurane and halothane in preschool-aged children undergoing bilateral myringotomy and pressure equalization tube insertion. Anesth Analg. 1999 Jan;88(1):34-8. doi: 10.1097/00000539-199901000-00007.

    PMID: 9895062BACKGROUND

  • Lynn AM, Bradford H, Kantor ED, Seng KY, Salinger DH, Chen J, Ellenbogen RG, Vicini P, Anderson GD. Postoperative ketorolac tromethamine use in infants aged 6-18 months: the effect on morphine usage, safety assessment, and stereo-specific pharmacokinetics. Anesth Analg. 2007 May;104(5):1040-51, tables of contents. doi: 10.1213/01.ane.0000260320.60867.6c.

    PMID: 17456651BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeOtitis Media

Interventions

KetorolacKetorolac TromethamineFentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsOtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Anica Crnkovic, MD

    Albany Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Farzana Afroze, MD

CONTACT

518-262-4300afrozef@mail.amc.edu

Anica Crnkovic, MD

CONTACT

518-262-4300CrnkovA@mail.amc.edu

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
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 12, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 13, 2021

Record last verified: 2021-09

Locations

US(1)