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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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ClinicalTrials.gov Identifier: NCT01198210
Recruitment Status : Unknown
Verified May 2013 by marzieh beigom khezri, Qazvin University Of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 10, 2010
Last Update Posted : May 7, 2013
Sponsor:
Information provided by (Responsible Party):
marzieh beigom khezri, Qazvin University Of Medical Sciences

Tracking Information
First Submitted Date  ICMJE September 1, 2010
First Posted Date  ICMJE September 10, 2010
Last Update Posted Date May 7, 2013
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
  • 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) ]
  • 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)) ]
  • 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)) ]
  • 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)) ]
  • 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)) ]
  • postoperative analgesic consumption [ Time Frame: during 24 h postoperative (in the ward) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
  • nausea, vomiting will be assessed by questioning their parents. [ Time Frame: during 60th min after extubation at postanesthesia care unit ]
  • bleeding will be assessed by questioning their parents [ Time Frame: during 24 h postoperative (in the ward) ]
  • family satisfaction will be assessed by questioning their parents. [ Time Frame: during 24 h postoperative (in the ward). ]
  • nausea, vomiting will be assessed by questioning their parents. [ Time Frame: during 24 h postoperative (in the ward) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
Official Title  ICMJE Comparison of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Tonsillectomy
Intervention  ICMJE
  • Drug: saline
    local peritonsillar infiltration of 2 ml saline,
  • Drug: Ketamine
    local peritonsillar infiltration of ketamine (0.5 mg/kg)
  • Drug: Dexamethasone
    local peritonsillar infiltration dexamethasone (0.2 mg/kg))
  • Drug: ketamine-dexamethasone
    local peritonsillar infiltration combination of ketamine0.5mg/kg-dexamethason 0.2mg/kg
Study Arms  ICMJE
  • Placebo Comparator: saline
    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: Drug: saline
  • Active Comparator: ketamine
    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: Drug: Ketamine
  • Active Comparator: dexamethasone
    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: Drug: Dexamethasone
  • Active Comparator: dexamethasone-ketamine
    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: Drug: ketamine-dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 9, 2010)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01198210
Other Study ID Numbers  ICMJE ACTRN12610000658011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party marzieh beigom khezri, Qazvin University Of Medical Sciences
Study Sponsor  ICMJE Qazvin University Of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Qazvin University Of Medical Sciences
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP