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Effects of intravenous dexmedetomidine and intravenous Apotel and combined of those (intravenous Apodex) on postoperative emergence agitation & pain

Clinical trial Comparison of intravenous dexmedetomidine and intravenous Apotel and combined of those (intravenous Apodex) on postoperative emergence agitation & pain after Adenotonsilectomy with Sevofloran in children

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016092930049N1
Enrollment
132
Registered
2017-04-12
Start date
2017-04-04
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

Adenotonsilectomy. Hypertrophy of tonsils with hypertrophy of adenoids

Interventions

Intervention 1: in group A 15 mg/kg of intravenous acetaminophen in 50 ml normal saline, will be infused 15 minutes before termination of surgery during 10 minutes. Intervention 2: in group D 1 mcg/kg
Treatment - Drugs
Placebo
in group A 15 mg/kg of intravenous acetaminophen in 50 ml normal saline, will be infused 15 minutes before termination of surgery during 10 minutes.
in group D 1 mcg/kg of intravenous dexmedetomidine in 50 ml normal saline, will be infused 15 minutes before termination of surgery during 10 minutes.
in group AD 10 mg/kg of intravenous acetaminophen and 0.3 mcg/kg dexmdetomidine in 50 ml normal saline, will be infused 15 minutes before termination of surgery during 10 minutes.
in group S or control group merely 50 ml normal saline, will be infused 15 minutes before termination of surgery during 10 minutes.

Sponsors

Vice chancellor for research of Kurdistan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: take Informed consent from parents to enter the study; patients between 2-12 old age candidate for Adenotonsilectomy; Physical status 1 and 2 classification of "American Society of Anesthesiologists" (ASA). Exclusion criteria: History of any cardiac, kidney, hepatic, or neurologic (convulsion) disease; Respiratory disease (Asthma or respiratory allergy); History of allergic reaction to the study drugs; History of upper airway infection in the last 4 weeks; use of any type of sedative drugs at the night before surgery; evidence of severe obstractive sleep apenea (OSA)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Emergence agitation. Timepoint: in advent to the recovery room (T0) and in 5,15,30 minutes thereafter and when the patient discharge from PACU. As well as 6 and 24 hours after discharge from PACU. Method of measurement: five score criteria described by Col for evaluate emergence agitation.;Pain. Timepoint: in advent to the recovery room (T0) and in 5,15,30 minutes thereafter and when the patient discharge from PACU. As well as 6 and 24 hours after discharge from PACU. Method of measurement: modified 10 score TPPPS criteria for evaluate of pain in children.

Secondary

MeasureTime frame
Delirium. Timepoint: in advent to the recovery room (T0) and in 5,15,30 minutes thereafter and when the patient discharge from PACU. As well as 6 and 24 hours after discharge from PACU. Method of measurement: 20 score PAED criteria for evaluate delirium in children.;Time to need the first rescue analgesic dose. Timepoint: Period of time from PACU admitance until the first need to analgesics. Method of measurement: By recording period of time between PACU admitance to the first need to analgesics.;Rate of need to analgesics. Timepoint: amount of analgesics usage for pain & EA relief. Method of measurement: By recording of amounts of analgesic usage in PACU & ward.;Nausea & vomiting. Timepoint: consideration for beeing Nausea & vomiting. Method of measurement: Have or not have.;Time of stay in PACU. Timepoint: Period of time from admitance to discharge from PACU. Method of measurement: recording period of time from admitance to discharge from PACU based on Aldrete criteria > 9.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Farzad Sarshivi

Kurdistan University of Medical Sciences

farzadsarshivi@gmail.com+98 87 3356 1356

Outcome results

None listed

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