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Celecoxib for Pediatric Adenotonsillectomy

17 april 2013 uppdaterad av: Kimmo Murto, Children's Hospital of Eastern Ontario

Celecoxib for Pediatric Adenotonsillectomy: A Randomized Controlled Double Blinded Study

The investigators' study will involve the administration of either placebo or celecoxib to children aged 2 to 18 years of age undergoing tonsillectomy and assessing pain relief, impact on quality of life and side effect profile.

Studieöversikt

Detaljerad beskrivning

The study will consist of two arms, one placebo and the other celecoxib. To establish baseline data on the day of surgery the parents will be required to complete a validated parent report quality of life inventory, multi-dimension fatigue scale and pediatric pain questionnaire for the preceding week. Children/adolescents aged 8 to 18 years of age will be required to complete a child self-report of the same modules. Children undergoing adenotonsillectomy will receive either placebo or celecoxib by mouth one hour prior to their surgery. They will all receive preoperative acetaminophen. Premedication with midazolam will be at the discretion of the attending anesthesiologist. The patients will undergo a standardized anesthetic protocol including postoperative management of pain and nausea and vomiting. The patients, while under anesthesia, will have blood drawn to screen for occult liver and kidney disease, determine their CYP2C9 genotype and reserve for future gene chip micro array analysis.

Patients in both study arms will receive a second dose of celecoxib or placebo by mouth in the evening after surgery and then consecutively in the morning and evening for 72 hours. For seven days after the surgery the families will record once a day pain scores, document analgesic use and any side effects or adverse events. The families will be contacted by phone in the evening of the first three postoperative days to ensure that they understand and are completing the required documentation. On the seventh postoperative day the parents and children aged 8 to 18 years of age will be contacted by phone and instructed to complete the same two validated questionnaires concerning quality of life and level of fatigue completed on the day of surgery. Parents of children less than eight years of age will be responsible for completing these questionnaires based on observations of their children. On the 11th postoperative day the families will be contacted by e-mail or regular mail to complete a questionnaire asking about the extent of contact with the healthcare system, bleeding complications, recovery and overall satisfaction with their care.

Studietyp

Interventionell

Inskrivning (Faktisk)

282

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Ontario
      • Ottawa, Ontario, Kanada, ON K1H 8L1
        • Children's Hospital of Eastern Ontario

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 år till 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Children aged 2-18 years
  • Tonsillectomy, or adenotonsillectomy
  • No exclusion criteria

Exclusion Criteria:

  • Age < 2yrs and >18yrs old
  • BMI < 10th or > 95th percentile
  • Serum creatinine (Cr) > 2 X UNL (upper normal limit)
  • Abnormal liver function; namely alanine aminotransferase (ALT) > 1.5 X UNL, alkaline phosphatase (ALP) > 5X UNL, total bilirubin > 2 X UNL
  • History of peptic ulcer disease.
  • History of bleeding disorders
  • History of severe asthma (requiring recent hospital admission or oral corticosteroid therapy)
  • Allergy to celecoxib, sulfonamide compounds or NSAIDs
  • Patients receiving CYP2C9 inhibitors fluconazole, amiodarone and oxandrolone
  • Patients receiving CYP2C9 inducers rifampin and phenobarbital
  • Extremes of body mass index (BMI) (age related below10th or above 90th percentile)
  • Parents of any participants, irrespective of age, who are unable to read and understand instructions relayed in English or French
  • Participant and/or parents of any participants, irrespective of age, who suffer from dementia, psychosis, significant developmental delay or other impairment that would prohibit the understanding and giving of informed consent or assent or the participation in self-care or toxicity reporting

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: B
Placebo

Patients will be randomized to receive celecoxib suspension 6 mg/kg one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of celecoxib (3 mg/kg) to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery.

All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO.

Andra namn:
  • celecoxib

Patients will be randomized to receive placebo by mouth one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of the placebo to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery.

All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO.

Andra namn:
  • Ora-Blend
Experimentell: A
Celebrex suspension

Patients will be randomized to receive celecoxib suspension 6 mg/kg one hour prior to their scheduled surgery. In addition the patient will receive seven weight-based doses of celecoxib (3 mg/kg) to be administered every 10-12 hours while the child is awake; the first dose being administered the evening of surgery.

All participants will receive undergo and post surgery anesthetic treatment according to the usual standards of practice at CHEO.

Andra namn:
  • celecoxib

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
The investigators primary objective will be to determine the level of postoperative pain relief celecoxib provides for children within the first three days after undergoing tonsillectomy, or adenotonsillectomy
Tidsram: three days
three days

Sekundära resultatmått

Resultatmått
Tidsram
To measure the frequency of adverse events post surgery
Tidsram: For seven days immediately after the procedure
For seven days immediately after the procedure
To quantify the impact of celecoxib on fatigue
Tidsram: Day 0 before the procedure and again on Day 7 afterwards
Day 0 before the procedure and again on Day 7 afterwards
To quantify the impact of celecoxib on quality of life
Tidsram: Day 0 before the procedure and again on Day 7 afterwards
Day 0 before the procedure and again on Day 7 afterwards
To quantify the impact of celecoxib on pain relief postsurgery
Tidsram: Day 0 before the procedure and every day until Day 7 afterwards
Day 0 before the procedure and every day until Day 7 afterwards
To identify polymorphisms of CYP2C9 genotypes and their impact on pain relief.
Tidsram: Sample taken during the procedure
Sample taken during the procedure

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Kimmo Murto, MD, FRCPC, Children's Hospital of Eastern Ontario

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2009

Primärt slutförande (Faktisk)

1 augusti 2012

Avslutad studie (Faktisk)

1 december 2012

Studieregistreringsdatum

Först inskickad

20 februari 2009

Först inskickad som uppfyllde QC-kriterierna

23 februari 2009

Första postat (Uppskatta)

24 februari 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

18 april 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 april 2013

Senast verifierad

1 april 2013

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Smärta, postoperativt

Kliniska prövningar på Celebrex suspension

3
Prenumerera