Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403806
Status:
TERMINATED
Last Update Posted:
2010-08-16
First Post:
2006-11-24
Brief Title:
Dexamethasone for Paediatric Adeno-tonsillectomy - A Dose-finding Study
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Antiemetic and Analgesic Efficacy and Safety of Dexamethasone for Paediatric Adeno-tonsillectomy - A Randomised Placebo-controlled Double-blind Dose-finding Study
Status:
TERMINATED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
drug-related harm
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 NSAIDswidely 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:
1 Primary objective To investigate the dose-effect relationship of prophylactic single-dose dexamethasone for the prevention of PONV in children undergoing adeno-tonsillectomy
2 Secondary objectiveTo 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
3 Study PopulationChildren 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
4 Randomisation and blindingChildren will be randomised to one of four groups of equal size
Group 1 Placebo NaCL 09Group 2Dexa 005 mgkg Group 3 Dexa 015 mgkg Group 4Dexa 05 mgkg
Indistinguishable 20 ml ampoules will be prepared and randomised by the Hospital Pharmacy Children will receive 05 mlkg 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
5 Variables measured
51 Intraoperatively
Type of surgery
Surgical time
Dose of opioid
52 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 µgkg IV or droperidol 20 µgkg 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 al1985 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 paracetamolcodeine 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 childs quality of sleep on a NRS ranging from 0did not sleep at all to 10excellent 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 0not satisfied at all to 10very much satisfied
Degree of stress on the part of the parents due to the childs illness Rated by the parents on a daily basis on a NRS scale from 0not stressed at all to 10very much stressed
At the surgical visit Overall satisfaction judged by the parents on a NRS ranging from 0not satisfied at all to 10very 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
2 Secondary objectiveTo 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
3 Study PopulationChildren 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
4 Randomisation and blindingChildren will be randomised to one of four groups of equal size
Group 1 Placebo NaCL 09Group 2Dexa 005 mgkg Group 3 Dexa 015 mgkg Group 4Dexa 05 mgkg
Indistinguishable 20 ml ampoules will be prepared and randomised by the Hospital Pharmacy Children will receive 05 mlkg 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
5 Variables measured
51 Intraoperatively
Type of surgery
Surgical time
Dose of opioid
52 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 µgkg IV or droperidol 20 µgkg 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 al1985 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 paracetamolcodeine 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 childs quality of sleep on a NRS ranging from 0did not sleep at all to 10excellent 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 0not satisfied at all to 10very much satisfied
Degree of stress on the part of the parents due to the childs illness Rated by the parents on a daily basis on a NRS scale from 0not stressed at all to 10very much stressed
At the surgical visit Overall satisfaction judged by the parents on a NRS ranging from 0not satisfied at all to 10very 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Swissmedic DR 3028 | None | None | None |