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Celecoxib for Pediatric Adenotonsillectomy

17 avril 2013 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

282

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

2 ans à 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: 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.

Autres noms:
  • célécoxib

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.

Autres noms:
  • Ora-Blend
Expérimental: 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.

Autres noms:
  • célécoxib

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
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
Délai: three days
three days

Mesures de résultats secondaires

Mesure des résultats
Délai
To measure the frequency of adverse events post surgery
Délai: For seven days immediately after the procedure
For seven days immediately after the procedure
To quantify the impact of celecoxib on fatigue
Délai: 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
Délai: 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
Délai: 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.
Délai: Sample taken during the procedure
Sample taken during the procedure

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Collaborateurs

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 août 2009

Achèvement primaire (Réel)

1 août 2012

Achèvement de l'étude (Réel)

1 décembre 2012

Dates d'inscription aux études

Première soumission

20 février 2009

Première soumission répondant aux critères de contrôle qualité

23 février 2009

Première publication (Estimation)

24 février 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

18 avril 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 avril 2013

Dernière vérification

1 avril 2013

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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