The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
Information source: Qazvin University Of Medical Sciences
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tonsillectomy
Intervention: saline (Drug); Ketamine (Drug); Dexamethasone (Drug); ketamine-dexamethasone (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Qazvin University Of Medical Sciences Overall contact:
Marzieh Beigom khezri, assistant professor, Phone: +98 9123811009, Email: mkhezri@qums.ac.ir
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.
Clinical Details
Official title: Comparison of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: 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: 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.
Eligibility
Minimum age: 3 Years.
Maximum age: 12 Years.
Gender(s): Both.
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, -
Locations and Contacts
Marzieh Beigom khezri, assistant professor, Phone: +98 9123811009, Email: mkhezri@qums.ac.ir
Qazvin university of medical science, Qazvin 34197/59811, Iran, Islamic Republic of; Recruiting
Marzieh Beigomb Khezri, assistant professor, Phone: +98 9123811009, Email: mkhezri@qums.ac.ir
Marzieh Beigom Khezri, assistant professor, Principal Investigator
Additional Information
Starting date: July 2010
Last updated: May 16, 2012
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