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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Qazvin University Of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
marzieh beigom khezri, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01198210
First received: September 1, 2010
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Tonsillectomy
Drug: saline
Drug: Ketamine
Drug: Dexamethasone
Drug: ketamine-dexamethasone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy

Resource links provided by NLM:


Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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)) ] [ Designated as safety issue: Yes ]
  • 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)) ] [ Designated as safety issue: Yes ]
  • 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)) ] [ Designated as safety issue: Yes ]
  • 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)) ] [ Designated as safety issue: Yes ]
  • postoperative analgesic consumption [ Time Frame: during 24 h postoperative (in the ward) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • nausea, vomiting will be assessed by questioning their parents. [ Time Frame: during 60th min after extubation at postanesthesia care unit ] [ Designated as safety issue: Yes ]
  • bleeding will be assessed by questioning their parents [ Time Frame: during 24 h postoperative (in the ward) ] [ Designated as safety issue: Yes ]
  • family satisfaction will be assessed by questioning their parents. [ Time Frame: during 24 h postoperative (in the ward). ] [ Designated as safety issue: Yes ]
  • nausea, vomiting will be assessed by questioning their parents. [ Time Frame: during 24 h postoperative (in the ward) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: saline
local peritonsillar infiltration of 2 ml 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).
Drug: Ketamine
local peritonsillar infiltration of ketamine (0.5 mg/kg)
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).
Drug: Dexamethasone
local peritonsillar infiltration dexamethasone (0.2 mg/kg))
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).
Drug: ketamine-dexamethasone
local peritonsillar infiltration combination of ketamine0.5mg/kg-dexamethason 0.2mg/kg

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198210

Contacts
Contact: Marzieh Beigom khezri, assistant professor +98 9123811009 mkhezri@qums.ac.ir

Locations
Iran, Islamic Republic of
Qazvin university of medical science Recruiting
Qazvin, Iran, Islamic Republic of, 34197/59811
Contact: Marzieh Beigomb Khezri, assistant professor    +98 9123811009    mkhezri@qums.ac.ir   
Principal Investigator: Marzieh Beigom Khezri, assistant professor         
Sponsors and Collaborators
Qazvin University Of Medical Sciences
  More Information

No publications provided

Responsible Party: marzieh beigom khezri, Assistant professor, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01198210     History of Changes
Other Study ID Numbers: ACTRN12610000658011
Study First Received: September 1, 2010
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Qazvin University Of Medical Sciences:
pain
tonsillectomy
peritonsillar infiltration
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Ketamine
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Anesthetics, Dissociative

ClinicalTrials.gov processed this record on October 01, 2014