- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01638052
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery
2. august 2021 opdateret af: Ann & Robert H Lurie Children's Hospital of Chicago
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery: Does the Addition of Clonidine Increase the Duration of Postoperative Analgesia?
The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
The surgical anesthesia during the operative procedure will be maintained using volatile anesthetics.
No prophylactic dexamethasone or ondansetron would be provided to any patients in either group.
Anesthesia will be discontinued at the end of the procedure and the patient will be extubated once standard extubation criteria have been met.
Patients will be then taken to the postoperative recovery room where they will be evaluated for pain and discomfort by a blinded observer using the CHIPPS (Children and Infants Postoperative Pain Scale).
If two consecutive pain scores at 5 minute intervals is >6, they will be rescued with incremental doses of 0.05 mg/kg of intravenous morphine required to reach a score of <6.
The number of rescue doses as well as the pain scores will be documented.
These patients will be also observed for the presence of nausea/vomiting.
Any patient who vomits more than two times will be rescued with ondansetron 0.1 mg/kg intravenously.
All patients will be continued to be evaluated in the 23 hour unit.
Pain and side effects will be assessed for the next 6 hours or until discharge from the 23 hour observation facility.
Standard doses of acetaminophen with codeine will be provided for pain relief in the 23 hour observational unit, as well as on discharge.
The number of doses of acetaminophen with codeine will be recorded.
Time to discharge from the hospital will also be noted.
A questionnaire designed to address parent/patient satisfaction will be utilized and will allude to the need for rescue analgesia and the need for any other additional analgesics provided.
The use of any additional rescue pain medication will be provided to the families at the time of discharge.
A follow-up phone call will be made in 24 hours to note the information provided on the questionnaire.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
56
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- age 1-18 years
- tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery)
- ASA I, II
- informed consent and assent obtained
Exclusion Criteria:
- allergic to local anesthestic
- taking chronic aspirin or Ibuprofen therapy
- ASA IV
- history of clinically important renal, hepatic, respiratory, cardiac, or neurological conditions
- Patients who have cardiovascular surgery other than an atrial septal defect or a ventricular septal defect, or who have undergone complete corrective intracardiac repair of congenital heart disease.
- Informed consent not obtained
- Patients expected to receive dexamethasone or ondansetron intra-operative
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: 0.25% Bupivacaine
This is our standard of care concentration
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Eksperimentel: 0.25% Bupivacaine + Clonidine
These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.
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Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Average Observer-Rated Patient Pain Scores
Tidsramme: 60 minutes
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Patients will be observed with behaviors rated at regular time intervals using the CHIPPS (Children and Infants Postoperative Pain Scale) pain survey.
The CHIPPS scale values range from a minimum of 0 (no pain, better outcome) to a maximum of 10 (worst pain, worse outcome).
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60 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Nausea/Vomiting
Tidsramme: 24 hours
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Incidence of nausea/vomiting during 24 hour observation
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24 hours
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Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively
Tidsramme: 24 hours
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Count of participants who will require use of rescue analgesic medication in the initial 24 hours postoperatively as recorded in the hospital or by parents at home following discharge.
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24 hours
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Santhanam Suresh, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Suresh S, Barcelona SL, Young NM, Seligman I, Heffner CL, Cote CJ. Postoperative pain relief in children undergoing tympanomastoid surgery: is a regional block better than opioids? Anesth Analg. 2002 Apr;94(4):859-62, table of contents. doi: 10.1097/00000539-200204000-00015.
- Wheeler M, Patel A, Suresh S, Roth AG, Birmingham PK, Heffner CL, Cote CJ. The addition of clonidine 2 microg.kg-1 does not enhance the postoperative analgesia of a caudal block using 0.125% bupivacaine and epinephrine 1:200,000 in children: a prospective, double-blind, randomized study. Paediatr Anaesth. 2005 Jun;15(6):476-83. doi: 10.1111/j.1460-9592.2005.01481.x.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2006
Primær færdiggørelse (Faktiske)
1. marts 2008
Studieafslutning (Faktiske)
1. april 2008
Datoer for studieregistrering
Først indsendt
9. juli 2012
Først indsendt, der opfyldte QC-kriterier
10. juli 2012
Først opslået (Skøn)
11. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. august 2021
Sidst verificeret
1. juli 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Keratose
- Kolesteatom
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Antihypertensive midler
- Depressive midler til centralnervesystemet
- Autonome agenter
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Bedøvelsesmidler
- Adrenerge alfa-2-receptoragonister
- Adrenerge alfa-agonister
- Adrenerge agonister
- Bedøvelsesmidler, lokale
- Sympatolytika
- Bupivacain
- Clonidin
Andre undersøgelses-id-numre
- CMH IRB 2005-12645
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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