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The Effects of Dexmedetomidine and Tramadol on Extubation Quality and Postoperative Pain and Agitation in Pediatric Patients Undergoing Adenotonsillectomy Surgery

The Effects of Dexmedetomidine and Tramadol on Extubation Quality and Postoperative Pain and Agitation in Pediatric Patients Undergoing Adenotonsillectomy Surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001268134
Enrollment
60
Registered
2019-09-12
Start date
2012-08-01
Completion date
2012-10-31
Last updated
2019-09-30

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

Conditions

None listed

Brief summary

Adenotonsillectomy is a common surgical procedure performed under general anesthesia in childhood. This surgical procedure may cause post-operative pain and agitation. Therefore it is important to provide effective pain control for diminishing post-operative morbidity. Dexmedetomidine and tramadol are among the drugs used for decreasig post-operative pain and agitation. The aim of our study is to compare the effects of dexmedetomidine and tramadol on post-operative pain and agitation, hemodynamic parameters and extubation quality in patients undergoing adenotonsillectomy surgery.

Interventions

Patients were taken to pre-operative preparation room with their parents about 30 minutes before the surgical operation. 0.4 mg/kg midazolam was given orally to the all patients in preparation room. Then, patients were monitored and taken to the operation room. Anesthesia was induced with 8% inspired sevoflurane in 50% nitrous oxide and 50% oxygen. After anesthesia induction, sevoflurane concentration is gradually reduced and an intravenous (i.v.) catheter was inserted. Patients were assigned to

Patients were taken to pre-operative preparation room with their parents about 30 minutes before the surgical operation. 0.4 mg/kg midazolam was given orally to the all patients in preparation room. Then, patients were monitored and taken to the operation room. Anesthesia was induced with 8% inspired sevoflurane in 50% nitrous oxide and 50% oxygen. After anesthesia induction, sevoflurane concentration is gradually reduced and an intravenous (i.v.) catheter was inserted. Patients were assigned to dexmedetomidine or tramadol group according to a computer generated program as follows: dexmedetomidine group (group D, n = 30) and tramadol group (group T, n = 30). Patients in group D received 1 µg/kg dexmedetomidine and patients in group T received 1.5 mg/kg tramadol. Both of these drugs were administered with a 10-minute i.v. infusion about 10 minutes before the end of the surgery. Patients were monitored, and mean arterial pressure (MAP) and heart rate (HR) were recorded. In addition to these variables, the Riker Sedation-Agitation Scale (SAS) was used for determining the level of anxiety of the patients, and pain point scale was used for determining the level of pain of the patients. Moreover, extubating time which was defined as the time from discontinuation of inhalation agent to removal of the endotracheal tube and extubation quality which was assessed by the presence of the following not breathing (> 20 second), coughing-bucking (frequency =4) and desaturation (saturation of O2 < 95%) after the extubation period were recorded for all patients. Dexmedetomidin group and tramadol groups were compared in terms of these variables. Anaesthetist will be administering the intervention.

Sponsors

Medeniyet University, Goztepe Training and Research Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
2 Years to 9 Years
Healthy volunteers
No

Inclusion criteria

A total of 60 children patients undergoing adenotonsillectomy surgery, aged between 2- 9 years and with American Society of Anesthesiologist (ASA) grades I or II, were included in this randomized study.

Exclusion criteria

Patients with a history of any chronic disease, ASA grades III or higher, blood pressure <100/50 mm Hg, heart rate < 60/bpm and known any allergy to study medications were excluded from the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026