Postoperative Nausea and VomitingPhase 4NCT00403806
Dexamethasone for Paediatric Adeno-tonsillectomy - A Dose-finding Study
A Phase 4 study testing dexamethasone and Saline in people with Postoperative Nausea and Vomiting and Postoperative Pain, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting, Postoperative Pain
- What is being tested?
- dexamethasone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2005to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Elective tonsillectomy with or without adenoidectomy with or without eartubes
Who cannot join
- ASA > II
- Allergie to Dexamethasone
- Recent therapy with steroids or immunotherapy
- Mental retardation
- Children experiencing nausea or vomiting or have taken antiemetic medication within 24 hours before surgery
- Additional surgery
Show all 10Show fewer
- Enrolement in another investigational study
- Chronic infection or diabetes
- Recent vaccination (less than 1 month prior to surgery)
- Recent varicella infection (less than 1 month prior to surgery)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Geneva, Anesthesia Department
Geneva, Canton of Geneva, 1211
About this study
Official title: Antiemetic and Analgesic Efficacy and Safety of Dexamethasone for Paediatric Adeno-tonsillectomy - A Randomised, Placebo-controlled, Double-blind, Dose-finding Study
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.
Read the detailed description
- Primary objective: To investigate the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of PONV in children undergoing adeno-tonsillectomy.
- Secondary objective:To investigate the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of postoperative pain and its effect on general outcome in children undergoing adeno-tonsillectomy. To investigate the safety of dexamethasone in children undergoing adeno-tonsillectomy.
- Study Population:Children, aged 3 to 16 years, scheduled for elective tonsillectomy with or without adenoidectomy, and with or without ear tubes will be included. Children will stay the first postoperative night at the hospital and will be discharged the day after surgery.
- Randomisation and blinding:Children will be randomised to one of four groups of equal size: Group 1: Placebo NaCL 0.9%,Group 2:Dexa 0.05 mg/kg, Group 3: Dexa 0.15 mg/kg, Group 4:Dexa 0.5 mg/kg Indistinguishable 20 ml ampoules will be prepared and randomised by the Hospital Pharmacy. Children will receive 0.5 ml/kg of the solution as an IV bolus after induction of anaesthesia. The maximum volume of dexamethasone injected will be limited to 20 ml (corresponding to a maximum dose of 20 mg in a child with ≥40 kg bodyweight). Standardized Anesthesia technique and surgical procedure
- Variables measured
5.1. Intraoperatively
- Type of surgery
- Surgical time
- Dose of opioid
5.2. Postoperatively
Follow up will be during the hospital stay, through a telephone interview 48 hours after surgery, and through a surgical control (standard procedure) at about one week. Preoperatively, parents and children will be instructed in the evaluation of pain. Parents will be given a questionnaire to be filled in twice daily (morning and evening) after discharge of the child, and to bring it back to the routine postoperative surgical control at one week (or to send it back by post).
Endpoint PONV
- Cumulative incidence of vomiting (including retching) during the first 6 postoperative hours.
- Cumulative incidence of nausea during the first 6 postoperative hours. Nausea is only recorded if the child is able to express the sensation of nausea.
- Cumulative incidence of vomiting (including retching) during the first 24 postoperative hours.
- Cumulative incidence of nausea during the first 24 postoperative hours. Rescue medication for PONV is with ondansetron (Zofran) 50 µg/kg IV or droperidol 20 µg/kg IV. Rescue antiemesis will be recorded.
Endpoint pain intensity In hospitalised children, pain assessment will be with the revised Faces Pain Scale (FPS-r) [Hicks et al, 2001] and with the conventional 0-10 cm Visual Analogue Scale (VAS). The FPS-r was adapted from the Faces Pain Scale [Bieri et al, 1990] in order to make it possible to score on the widely accepted 0-10 point metric. It shows a close linear relationship with the visual analogue pain scale across the age range from 4 to 16 years. In the case that a younger child is not able to express adequately its pain with the FPS-r or with the VAS we will use the CHEOP Scale (Children of Eastern Ontario Pain Scale); this is a behavioural observation scale [McGrath et al,1985]. Pain will be evaluated at arriving in the PACU, 1-hourly during the PACU stay, 4-hourly on the ward, and twice daily after discharge (see questionnaire). Sleeping children will not be woken up.
Cumulative doses per day of paracetamol/codeine and of any other analgesic (NSAIDs, opioids) will be recorded.
Further endpoints
- Quality of sleep during each the night until the surgical visit. Each morning, the care-giver (nurse, parent) will estimate the child's quality of sleep on a NRS ranging from 0=did not sleep at all to 10=excellent sleep.
- First oral intake of fluid (including ice cream); hours after end of surgery.
- First oral intake of solid food; hours after end of surgery.
- At discharge: Overall "satisfaction" judged by the nurse on a NRS ranging from 0=not satisfied at all to 10=very much satisfied.
- Degree of stress on the part of the parents due to the child's "illness". Rated by the parents on a daily basis on a NRS scale from 0=not stressed at all to 10=very much stressed.
- At the surgical visit: Overall "satisfaction" judged by the parents on a NRS ranging from 0=not satisfied at all to 10=very much satisfied.
Adverse effects, safety
- Any minor complication: definition: no need for readmission.
- Any major complication: definition: does need readmission (for instance, readmission due to bleeding, re-operation due to bleeding).
- Being tested
- dexamethasone, Saline
- Keywords
- Adenotonsillectomy, Pediatrics, Postoperative Nausea and Vomiting, Pain, Oral intake, Dexamethasone, Dose finding
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Also called Mephamesone
intravenous dexamethasone 0.05 mg per kg bodyweight
DexamethasoneDrug
Also called mephamesone
Intravenous dexamethasone 0.15 mg per kg bodyweight
dexamethasoneDrug
Also called mephamesone
Intravenous dexamethasone 0.5 mg per kg bodyweight
SalineDrug
Also called mephamesone
Intravenous saline
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Intravenous dexamethasone 0.05 mg per kg bodyweight Receives: Drug: dexamethasone |
| 2 | Active comparator | Intravenous dexamethasone 0.15 mg per kg bodyweight Receives: Drug: Dexamethasone |
| 3 | Active comparator | Intravenous dexamethasone 0.5 mg per kg bodyweight Receives: Drug: dexamethasone |
| 4 | Placebo comparator | Intravenous saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of postoperative nausea and vomiting in children undergoing adeno-tonsillectomy
Measured: 24 hours postoperatively
Secondary outcomes (4)
Dose-effect relationship for the prevention of postoperative pain
Measured: 24 hours postoperatively
Oral intake
Measured: 10 days
Effect on general outcome
Measured: 10 days
Investigation of safety (drug-related harm)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startFeb 2005
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: drug-related harm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Christoph A Czarnetzki, MD, MBA, Principal investigator, anesthesia departmentMartin Tramer, MD, PhD, Study chair, anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403806
- Sponsor's protocol ID
- NAC 04-005
- Other IDs
- Swissmedic DR 3028
- Status last verified
- Jan 2009
- First submitted
- 24 Nov 2006
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Czarnetzki C, Elia N, Lysakowski C, Dumont L, Landis BN, Giger R, Dulguerov P, Desmeules J, Tramer MR. Dexamethasone and risk of nausea and vomiting and postoperative bleeding after tonsillectomy in children: a randomized trial. JAMA. 2008 Dec 10;300(22):2621-30. doi: 10.1001/jama.2008.794.
PubMed 19066382
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiemetic and Analgesic Efficacy and Safety of Dexamethasone for Paediatric Adeno-tonsillectomy - A Randomised, Placebo-controlled, Double-blind, Dose-finding Study
- ClinicalTrials.gov ID
- NCT00403806
- Acronym / sponsor ID
- NAC 04-005
- Keywords
- Adenotonsillectomy, Pediatrics, Postoperative Nausea and Vomiting, Pain, Oral intake, Dexamethasone, Dose finding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: drug-related harm
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Primary objective: To investigate the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of PONV in children undergoing adeno-tonsillectomy.
- Secondary objective:To investigate the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of postoperative pain and its effect on general outcome in children undergoing adeno-tonsillectomy. To investigate the safety of dexamethasone in children undergoing adeno-tonsillectomy.
- Study Population:Children, aged 3 to 16 years, scheduled for elective tonsillectomy with or without adenoidectomy, and with or without ear tubes will be included. Children will stay the first postoperative night at the hospital and will be discharged the day after surgery.
- Randomisation and blinding:Children will be randomised to one of four groups of equal size: Group 1: Placebo NaCL 0.9%,Group 2:Dexa 0.05 mg/kg, Group 3: Dexa 0.15 mg/kg, Group 4:Dexa 0.5 mg/kg Indistinguishable 20 ml ampoules will be prepared and randomised by the Hospital Pharmacy. Children will receive 0.5 ml/kg of the solution as an IV bolus after induction of anaesthesia. The maximum volume of dexamethasone injected will be limited to 20 ml (corresponding to a maximum dose of 20 mg in a child with ≥40 kg bodyweight). Standardized Anesthesia technique and surgical procedure
- Variables measured
5.1. Intraoperatively
- Type of surgery
- Surgical time
- Dose of opioid
5.2. Postoperatively
Follow up will be during the hospital stay, through a telephone interview 48 hours after surgery, and through a surgical control (standard procedure) at about one week. Preoperatively, parents and children will be instructed in the evaluation of pain. Parents will be given a questionnaire to be filled in twice daily (morning and evening) after discharge of the child, and to bring it back to the routine postoperative surgical control at one week (or to send it back by post).
Endpoint PONV
- Cumulative incidence of vomiting (including retching) during the first 6 postoperative hours.
- Cumulative incidence of nausea during the first 6 postoperative hours. Nausea is only recorded if the child is able to express the sensation of nausea.
- Cumulative incidence of vomiting (including retching) during the first 24 postoperative hours.
- Cumulative incidence of nausea during the first 24 postoperative hours. Rescue medication for PONV is with ondansetron (Zofran) 50 µg/kg IV or droperidol 20 µg/kg IV. Rescue antiemesis will be recorded.
Endpoint pain intensity In hospitalised children, pain assessment will be with the revised Faces Pain Scale (FPS-r) [Hicks et al, 2001] and with the conventional 0-10 cm Visual Analogue Scale (VAS). The FPS-r was adapted from the Faces Pain Scale [Bieri et al, 1990] in order to make it possible to score on the widely accepted 0-10 point metric. It shows a close linear relationship with the visual analogue pain scale across the age range from 4 to 16 years. In the case that a younger child is not able to express adequately its pain with the FPS-r or with the VAS we will use the CHEOP Scale (Children of Eastern Ontario Pain Scale); this is a behavioural observation scale [McGrath et al,1985]. Pain will be evaluated at arriving in the PACU, 1-hourly during the PACU stay, 4-hourly on the ward, and twice daily after discharge (see questionnaire). Sleeping children will not be woken up.
Cumulative doses per day of paracetamol/codeine and of any other analgesic (NSAIDs, opioids) will be recorded.
Further endpoints
- Quality of sleep during each the night until the surgical visit. Each morning, the care-giver (nurse, parent) will estimate the child's quality of sleep on a NRS ranging from 0=did not sleep at all to 10=excellent sleep.
- First oral intake of fluid (including ice cream); hours after end of surgery.
- First oral intake of solid food; hours after end of surgery.
- At discharge: Overall "satisfaction" judged by the nurse on a NRS ranging from 0=not satisfied at all to 10=very much satisfied.
- Degree of stress on the part of the parents due to the child's "illness". Rated by the parents on a daily basis on a NRS scale from 0=not stressed at all to 10=very much stressed.
- At the surgical visit: Overall "satisfaction" judged by the parents on a NRS ranging from 0=not satisfied at all to 10=very much satisfied.
Adverse effects, safety
- Any minor complication: definition: no need for readmission.
- Any major complication: definition: does need readmission (for instance, readmission due to bleeding, re-operation due to bleeding).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: dexamethasoneIntravenous dexamethasone 0.05 mg per kg bodyweight |
| 2 | Active comparator | Drug: DexamethasoneIntravenous dexamethasone 0.15 mg per kg bodyweight |
| 3 | Active comparator | Drug: dexamethasoneIntravenous dexamethasone 0.5 mg per kg bodyweight |
| 4 | Placebo comparator | Drug: SalineIntravenous saline |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Elective tonsillectomy with or without adenoidectomy with or without eartubes
Key exclusion criteria (10 listed)
- ASA > II
- Allergie to Dexamethasone
- Recent therapy with steroids or immunotherapy
- Mental retardation
- Children experiencing nausea or vomiting or have taken antiemetic medication within 24 hours before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasoneAlso: Mephamesoneintravenous dexamethasone 0.05 mg per kg bodyweight | Drug | 1 |
| DexamethasoneAlso: mephamesoneIntravenous dexamethasone 0.15 mg per kg bodyweight | Drug | 2 |
| dexamethasoneAlso: mephamesoneIntravenous dexamethasone 0.5 mg per kg bodyweight | Drug | 3 |
| SalineAlso: mephamesoneIntravenous saline | Drug | 4 |
Primary outcome
Investigation of the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of postoperative nausea and vomiting in children undergoing adeno-tonsillectomy
Time frame: 24 hours postoperatively
4 secondary outcomes
Dose-effect relationship for the prevention of postoperative pain
Time frame: 24 hours postoperatively
Oral intake
Time frame: 10 days
Effect on general outcome
Time frame: 10 days
Investigation of safety (drug-related harm)
Time frame: 10 days
Results and safety
The study was stopped early (reason given: drug-related harm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
- Results publication: PubMed 19066382Czarnetzki C, Elia N, Lysakowski C, Dumont L, Landis BN, Giger R, Dulguerov P, Desmeules J, Tramer MR. Dexamethasone and risk of nausea and vomiting and postoperative bleeding after tonsillectomy in children: a randomized trial. JAMA. 2008 Dec 10;300(22):2621-30. doi: 10.1001/jama.2008.794.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph A Czarnetzki, MD, MBA principal investigator
anesthesia department
Martin Tramer, MD, PhD study chair
anesthesia department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone and Saline in people with Postoperative Nausea and Vomiting and Postoperative Pain, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: drug-related harm). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of postoperative nausea and vomiting in children undergoing adeno-tonsillectomy (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00403806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2010.