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The effects of peritonsillar injection of ketamine or tramadol on the post tonsillectomy pain

Comparison of the effects of peritonsillar injection of ketamine with tramadol on the post tonsillectomy pain

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201103255764N2
Enrollment
126
Registered
2011-04-25
Start date
2010-05-31
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: ?Effect of tramadol on post tonsillectomy pain. Condition 2: Effect of ketamine on the post tonsillectomy pain. Opioids and related analgesics Other and unspecified general anaesthetics

Interventions

Intervention 1: Ketamine infiltration in volume 2 cc - 0.5mg / kg, 1 cc into the area the submucousal of anterior fossa and beds of each tonsils after intubation, and three minutes before surgery sta
Prevention
Ketamine infiltration in volume 2 cc - 0.5mg / kg, 1 cc into the area the submucousal of anterior fossa and beds of each tonsils after intubation, and three minutes before surgery starting.
Tramadol infiltration in volume 2 cc - 2mg / kg, 1 cc into the area the submucousal of anterior fossa and beds of each tonsils after intubation, and three minutes before surgery starting.
Normal saline infilttration in volume 2 cc - 1 cc into the area the submucousal of anterior fossa and beds of each tonsils after intubation, and three minutes before surgery starting.

Sponsors

Vice chancellor for research, .... University of shahid sadoughi medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1); 5-12 yr patients, who are candidate for elective bilateral tonsillectomy due to chronic or recurrent tonsillitis ; 2);ASA class =I,II (American society of anesthesiology); 3) ;No evidence of difficult air way management: 4);Without cardio, pulmonary, endocrine, psycho and metabolic disease; 5);Do not use analgesic drugs in the last 24 hours; 6);No electrolyte abnormalities; 7);No tonsillectomy indication except chronic or recurrent tonsillitis; 8);No mental, cerebral and growth problems; 9);No sore throat Exclusion criteria: 1) ;surgery time > 1 hour; 2) ;History of reaction to drugs studies; 3) ;Unexpected problems during anesthesia and surgery (excessive bleeding, difficult intubation,...); 4) ;Cauterization that used during surgery

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Post-tonsillectomy pain. Timepoint: Each 10 min in the recovery room until 1 hour. Then each 2 hour until 12 hour in the ward. Method of measurement: ;CHEOPS score;.

Secondary

MeasureTime frame
Sedation. Timepoint: 2- 4- 6- 8- 12 hours post interance to ward. Method of measurement: RAMSY score.;Systolic, diastolic, mean blood pressure. Timepoint: Each 5 min during surgery, 5- 10 - 15- 30- 60 min in the recovery. Method of measurement: Non invasive blood pressure.;Negative Behaviors and hallucination. Timepoint: In the recovery room. Method of measurement: Visual.;Heart rate. Timepoint: Each 5 min during surgery, 5- 10 - 15- 30- 60 min in the recovery. Method of measurement: EKG.;Nausea, vomiting. Timepoint: IN the recoverey room until 1 hour and in ward until 12 hours. Method of measurement: Visual and Asking the patient and her or his parents.;Thr first time if needed analgesic. Timepoint: In the recovery and ward. Method of measurement: VAS.;Starting time of fluids. Timepoint: In the ward. Method of measurement: Visual and Asking the patient and her or his parents.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Vida Ayatollahi

Yazd University of Medical Sciences

ayatt.vida@ssu.ac.ir; ayati.vida@yahoo.com+98 35 1822 4001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026