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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]

'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

Condition category

Condition code

Anaesthesiology

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]

Prevention

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

received a local peritonsillar infiltration of 2 ml saline,

Control group

Placebo

Outcomes

Primary outcome [1]

Modified Hannallah pain scale [observational pain scores (OPS)]

Timepoint [1]

first, 15th, 30th and 60th min postoperatively( After extubation when the patients were taken to the postanesthesia care unit (PACU).

Primary outcome [2]

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]

first, 15th, 30th and 60th min after exubation (at postanesthesia care unit [PACU]and 24 h postoperative(in the ward)

Secondary outcome [1]

nausea, vomiting will be assessed by questioning their parents.

Timepoint [1]

first, 15th, 30th and 60th min after extubation at postanesthesia care unit and 24 h postoperative(in the ward)

Secondary outcome [2]

bleeding will be assessed by questioning their parents.

Timepoint [2]

24 h postoperative(in the ward)

Secondary outcome [3]

sedation and Aldrete scores

Timepoint [3]

first, 15th, 30th and 60th min after extubation at postanesthesia care unit.

Secondary outcome [4]

family satisfaction will be assessed by questioning their parents.

Timepoint [4]

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?

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]

Iran, Islamic Republic Of

State/province [1]

qazvin

Country [2]

Iran, Islamic Republic Of

State/province [2]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Marzieh Beigom Khezri,

Address [1]

Marzieh Beigom Khezri, , Department of Anesthesiology ,Qazvin University of Medical Science. Iran ,qazvin-boulvar bahonar postal code:34188 99578

Country [1]

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]

Hospital

Name [1]

Ghods hospital

Address [1]

qazvin .boulvar shahid beheshti
postal code:34159-14595

Country [1]

Iran, Islamic Republic Of

Other collaborator category [1]

Individual

Name [1]

fatemeh khalili

Address [1]

qazvin .naderi street,postal code
:24137-73691

Country [1]

Iran, Islamic Republic Of

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

qazvin mediccal science university

Ethics committee address [1]

shahid bahonar,Ave3419759811 Qazvin ,Iran postal code:34197/59811

Ethics committee country [1]

Iran, Islamic Republic Of

Date submitted for ethics approval [1]

20/06/2010

Approval date [1]

29/07/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Marzieh Beigom Khezri

Address

Department of Anesthesiology ,Qazvin University of Medical Science, Iran ,qazvin-boulvar bahonar
postal code:34188 99578

Country

Iran, Islamic Republic Of

Phone

+98-912-3811009

Fax

+98-281-2236378

mkhezri@qums.ac.ir

Contact person for scientific queries

Name

Marzieh Beigom Khezri

Address

Department of Anesthesiology ,Qazvin University of Medical Science, Iran ,qazvin-boulvar bahonar
postal code:34188 99578

Country

Iran, Islamic Republic Of

Phone

+98-912-3811009

Fax

+98-281-2236378

mkhezri@qums.ac.ir

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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