The Effect of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy
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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 |
- 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 ]
- 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 |
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| Contact: Marzieh Beigom khezri, assistant professor | +98 9123811009 | mkhezri@qums.ac.ir |
| 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 | |
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 Ketamine Dexamethasone Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antiemetics Autonomic Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 18, 2013