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The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy

Primary Purpose

Tonsillectomy

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
saline
Ketamine
Dexamethasone
ketamine-dexamethasone
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tonsillectomy focused on measuring pain, tonsillectomy, peritonsillar infiltration, postoperative pain

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children age 3-12 years ASAI,II

Exclusion Criteria:

  • contraindication for usage of Ketamine, dexamethasone
  • upper respiratory tract infection
  • increase intracranial pressure( ICP)
  • history of allergy ,seizure,psychiatric illness, , bleeding disorders
  • chronic usage of analgesic ,antiemetic ,stroied drugs two weeks before surgery,
  • history of peritonsillar abscess, , tonsillitis within two weeks, -

Sites / Locations

  • Qazvin university of medical scienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

saline

ketamine

dexamethasone

dexamethasone-ketamine

Arm Description

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 dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 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).

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 dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 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).

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 dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 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).

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 dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 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).

Outcomes

Primary Outcome Measures

pain will be assessed by [observational pain scores (OPS)]
pain will be assessed by [observational pain scores (OPS)]
pain will be assessed by [observational pain scores (OPS)]
pain will be assessed by [observational pain scores (OPS)]
time to first demand of analgesia
postoperative analgesic consumption

Secondary Outcome Measures

nausea, vomiting will be assessed by questioning their parents.
bleeding will be assessed by questioning their parents
family satisfaction will be assessed by questioning their parents.
nausea, vomiting will be assessed by questioning their parents.

Full Information

First Posted
September 1, 2010
Last Updated
May 6, 2013
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01198210
Brief Title
The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
Official Title
Comparison of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 non-steroidal anti-inflammatory 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 dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg dexamethasone 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. 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 thiopental 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillectomy
Keywords
pain, tonsillectomy, peritonsillar infiltration, postoperative pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
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 dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 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).
Arm Title
ketamine
Arm Type
Active Comparator
Arm Description
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 dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 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).
Arm Title
dexamethasone
Arm Type
Active Comparator
Arm Description
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 dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 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).
Arm Title
dexamethasone-ketamine
Arm Type
Active Comparator
Arm Description
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 dexamethsone (0.2 mg/kg)) , group K ketamine (0.5 mg/kg) and group KD combination of ketamine0.5mg/kg-dexamethasone 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 Type
Drug
Intervention Name(s)
saline
Intervention Description
local peritonsillar infiltration of 2 ml saline,
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
local peritonsillar infiltration of ketamine (0.5 mg/kg)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
local peritonsillar infiltration dexamethasone (0.2 mg/kg))
Intervention Type
Drug
Intervention Name(s)
ketamine-dexamethasone
Intervention Description
local peritonsillar infiltration combination of ketamine0.5mg/kg-dexamethason 0.2mg/kg
Primary Outcome Measure Information:
Title
pain will be assessed by [observational pain scores (OPS)]
Time Frame
5 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU)
Title
pain will be assessed by [observational pain scores (OPS)]
Time Frame
15th min postoperatively (15 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
Title
pain will be assessed by [observational pain scores (OPS)]
Time Frame
30th min postoperatively (30 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
Title
pain will be assessed by [observational pain scores (OPS)]
Time Frame
60thmin postoperatively (60 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
Title
time to first demand of analgesia
Time Frame
during 60min postoperatively (during 60 minutes After extubation when the patients were taken to the postanesthesia care unit (PACU))
Title
postoperative analgesic consumption
Time Frame
during 24 h postoperative (in the ward)
Secondary Outcome Measure Information:
Title
nausea, vomiting will be assessed by questioning their parents.
Time Frame
during 60th min after extubation at postanesthesia care unit
Title
bleeding will be assessed by questioning their parents
Time Frame
during 24 h postoperative (in the ward)
Title
family satisfaction will be assessed by questioning their parents.
Time Frame
during 24 h postoperative (in the ward).
Title
nausea, vomiting will be assessed by questioning their parents.
Time Frame
during 24 h postoperative (in the ward)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children age 3-12 years ASAI,II Exclusion Criteria: contraindication for usage of Ketamine, dexamethasone upper respiratory tract infection increase intracranial pressure( ICP) history of allergy ,seizure,psychiatric illness, , bleeding disorders chronic usage of analgesic ,antiemetic ,stroied drugs two weeks before surgery, history of peritonsillar abscess, , tonsillitis within two weeks, -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marzieh Beigom khezri, assistant professor
Phone
+98 9123811009
Email
mkhezri@qums.ac.ir
Facility Information:
Facility Name
Qazvin university of medical science
City
Qazvin
ZIP/Postal Code
34197/59811
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marzieh Beigomb Khezri, assistant professor
Phone
+98 9123811009
Email
mkhezri@qums.ac.ir
First Name & Middle Initial & Last Name & Degree
Marzieh Beigom Khezri, assistant professor

12. IPD Sharing Statement

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The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy

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