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Trial registered on ANZCTR


Registration number
ACTRN12610000658011
Ethics application status
Approved
Date submitted
5/08/2010
Date registered
12/08/2010
Date last updated
12/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of peritonsillar
infiltration of ketamine and dexamethason for postoperative pain
relief in children following adenotonsillectomy
Scientific title
The effect of peritonsillar
infiltration of ketamine and dexamethason for postoperative pain
relief in children following adenotonsillectomy
Secondary ID [1] 252365 0
'None
Universal Trial Number (UTN)
U1111-1116-3950
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative pain after tonsillectomy 257877 0
Condition category
Condition code
Anaesthesiology 258040 258040 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One hundred sixtyAmerican Society of Anesthesiologists
(ASA) I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethson (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethason 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy( all four groups).
Intervention code [1] 256931 0
Prevention
Intervention code [2] 256997 0
Treatment: Drugs
Comparator / control treatment
received a local peritonsillar infiltration of 2 ml saline,
Control group
Placebo

Outcomes
Primary outcome [1] 258888 0
Modified Hannallah pain scale [observational pain scores (OPS)]
Timepoint [1] 258888 0
first, 15th, 30th and 60th min postoperatively( After extubation when the patients were taken to the postanesthesia care unit (PACU).
Primary outcome [2] 258895 0
time to first demand of analgesia and 24h postoperative analgesic consumption this outcome will be assessed by Modified Hannallah pain scale [observational pain scores (OPS)] and using a four-point scale: 0 no pain, 1 mild pain, 2 moderate pain, 3 severe pain by questioning their parents .
Timepoint [2] 258895 0
first, 15th, 30th and 60th min after exubation (at postanesthesia care unit [PACU]and 24 h postoperative(in the ward)
Secondary outcome [1] 265042 0
nausea, vomiting will be assessed by questioning their parents.
Timepoint [1] 265042 0
first, 15th, 30th and 60th min after extubation at postanesthesia care unit and 24 h postoperative(in the ward)
Secondary outcome [2] 265047 0
bleeding will be assessed by questioning their parents.
Timepoint [2] 265047 0
24 h postoperative(in the ward)
Secondary outcome [3] 265052 0
sedation and Aldrete scores
Timepoint [3] 265052 0
first, 15th, 30th and 60th min after extubation at postanesthesia care unit.
Secondary outcome [4] 265053 0
family satisfaction will be assessed by questioning their parents.
Timepoint [4] 265053 0
24 h postoperative( in the ward).

Eligibility
Key inclusion criteria
children age 3-12 years ASAI,II undergoing elective tonsillectomy
Minimum age
3 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
contraindication for usage of Ketamine, dexamethason, (upper respiratory tract infection, increase intracranial pressure( ICP), open eye surgery, seizure) ,history of alergy ,chronic usage of analgesic ,antiemetic ,stroied drugs before surgery, history of peritonsillar abscess, , tonsillitis within two weeks, pain before surgery, psychiatric illness, , bleeding disorders and other surgical procedures during the same operation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment is decided and permission of the patient is obtained by two of the anesthesiologists during preoperative rounding,.This is a double blinded clinical trial, with blinding of both the patient and the administrating practitioner to the anaesthetic type. Allocation will be managed by a Resident external to the project. The blinding will occur through use of equal amounts of pretreatment drugs (2ml’s) Each syringe will be labeled A ,B,C orD according to its contents. . The drug syringes are handed over to anesthesiologists blinded to the patient allocation to carry out the induction of anesthesia .All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy.At PACU a nurse who were unaware of the study drug observed the patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated table of
numbers guided randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 2797 0
Iran, Islamic Republic Of
State/province [1] 2797 0
qazvin
Country [2] 2798 0
Iran, Islamic Republic Of
State/province [2] 2798 0

Funding & Sponsors
Funding source category [1] 257446 0
Self funded/Unfunded
Name [1] 257446 0
Marzieh Beigom Khezri,
Country [1] 257446 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Qazvin University of Medical Science.
Address
Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar postal code:34188 99578
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 256620 0
Hospital
Name [1] 256620 0
Ghods hospital
Address [1] 256620 0
qazvin .boulvar shahid beheshti
postal code:34159-14595
Country [1] 256620 0
Iran, Islamic Republic Of
Other collaborator category [1] 251418 0
Individual
Name [1] 251418 0
fatemeh khalili
Address [1] 251418 0
qazvin .naderi street,postal code
:24137-73691
Country [1] 251418 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259397 0
qazvin mediccal science university
Ethics committee address [1] 259397 0
shahid bahonar,Ave3419759811 Qazvin ,Iran postal code:34197/59811
Ethics committee country [1] 259397 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 259397 0
20/06/2010
Approval date [1] 259397 0
29/07/2010
Ethics approval number [1] 259397 0
d/20/1629

Summary
Brief summary
Objective:
The immediate postoperative period after tonsillectomy, , is often difficult. These children frequently have severe pain but postoperative airway edema along with increased sensitivity to the respiratory-depressant effects of opioids may result in obstructive symptoms and hypoxemia. Opioid consumption may be reduced by nonsteroidal antiinflammatory drugs, but these drugs may be associated with increased bleeding after this operation.
Methods: One hundred sixty ASA I-II children 3-12 were randomized four groups of 40 each. Group P received a local peritonsillar infiltration of 2 ml saline, group D dexamethson (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg dexamethason 0.2mg/kg. All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy. Study drugs were marked only with a coded number label. A computer-generated table of numbers guided randomization. .
Exclusion criteria were: history of peritonsillar abscess, previous tonsil surgery, tonsillitis within two weeks, pain before surgery, psychiatric illness, asymmetrical tonsils, chronic analgesic usage, bleeding disorders and other surgical procedures during the same operation, Children who received antiemetics, steroids, anti-histaminic, or psychoactive drugs during the week before surgery. Modified Hannallah pain scale [observational pain scores (OPS)], nausea, vomiting, bleeding, rescue analgesia, sedation and Aldrete scores were recorded at first, 15th, 30th and 60th min postoperatively. Patients were interviewed on the day after surgery to assess the postoperative pain, nightmares, hallucinations, vomiting and bleeding. All the children were premedicated with midazolam hydrochloride 0.3 mg/kg) and fentanyl 1micro g/kg intavenously. Anesthesia was induced with thiopenthal 5mg/kg and atracurium0.3mg/kg. Anesthesia was maintained with isoflurane 1.5% and nitrous oxide 30% in oxygen. The two surgeon used the same dissection and snare technique for all cases and hemostasis done with bipolar cutter. At the end of the surgery neuromuscular blockade was reversed by neostigmine 0.03 mg/kg) and atropine 0.01 mg/kg intravenously), anesthesia was discontinued and the tracheal tube removed in the operating room when patients were deep. After extubation the patients were taken to the postanesthesia care unit (PACU) where an nurse who were unaware of the study drug observed the patients. The pain scoring observer nurse in PACU was consistent. Time to awaken (from the end of anesthesia until the patients opened their eyes on command) and time to the first administration of postoperative analgesia were recorded. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients with a OPS score > 4 or who were crying during two consecutive five minute observation periods until the child was comfortable. Postoperative pain during the first 24 h was assessed using a four-point scale: 0 no pain, 1 mild pain, 2 moderate pain, 3 severe pain by questioning their parents. In the ward the standardized postoperative analgesic technique was with acetaminophen supp (40 mg/kg followed by three doses of 20 mg/kg at 6-hour intervals to be given as needed for pain. Pethidine in a titrated dose (total 1 mg/kg) was administered intravenously for rapid pain relief to patients who had pain scale >3.Any supplementary analgesia , nausea and vomiting, bleeding, sleep disturbance and nightmares that the child might have had as surgery were assessed during a telephone follow up 24 h later. The time needed for first demand of analgesia and analgesic consumption to reduce the OPS for resting throat pain to <4 and 24-h pethidine and supp acetaminophen consumptionwere recored.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31464 0
Address 31464 0
Country 31464 0
Phone 31464 0
Fax 31464 0
Email 31464 0
Contact person for public queries
Name 14711 0
Marzieh Beigom Khezri
Address 14711 0
Department of Anesthesiology ,Qazvin University of Medical Science, Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 14711 0
Iran, Islamic Republic Of
Phone 14711 0
+98-912-3811009
Fax 14711 0
+98-281-2236378
Email 14711 0
mkhezri@qums.ac.ir
Contact person for scientific queries
Name 5639 0
Marzieh Beigom Khezri
Address 5639 0
Department of Anesthesiology ,Qazvin University of Medical Science, Iran ,qazvin-boulvar bahonar
postal code:34188 99578
Country 5639 0
Iran, Islamic Republic Of
Phone 5639 0
+98-912-3811009
Fax 5639 0
+98-281-2236378
Email 5639 0
mkhezri@qums.ac.ir

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