MedTrace Logo

Dexamethasone for Paediatric Adeno-tonsillectomy - A Dose-finding Study

NCT00403806 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2010-08-16

No results posted yet for this study

Summary

Adeno-tonsillectomy is a commonly performed surgical procedure in children. Main morbidities are postoperative pain, nausea and vomiting, and haemorrhage. Non-steroidal anti-inflammatory drugs (NSAIDs)widely used for paincontrol increase the risk of postoperative bleeding and reoperation. Dexamethasone is an powerful antiemetic and has shown analgesic efficacy. Antiemetic and analgesic dose-response has never been established.

Conditions

  • Postoperative Nausea and Vomiting
  • Postoperative Pain

Interventions

DRUG

dexamethasone

intravenous dexamethasone 0.05 mg per kg bodyweight

DRUG

Dexamethasone

Intravenous dexamethasone 0.15 mg per kg bodyweight

DRUG

dexamethasone

Intravenous dexamethasone 0.5 mg per kg bodyweight

DRUG

Saline

Intravenous saline

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Christoph A Czarnetzki, MD, MBA · anesthesia department

  • Martin Tramer, MD, PhD · anesthesia department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00403806 on ClinicalTrials.gov