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Effect of Gabapantin versus Midazolam in Tonsillectomy

Comparison of Sedative effect of Midazolan and Gabapantin in Pre-Tonsillectomy in Pediatric

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191103045320N1
Enrollment
108
Registered
2019-12-12
Start date
2019-11-26
Completion date
Unknown
Last updated
2019-12-17

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

Conditions

Tonsilectomy.

Interventions

Intervention group: One Gabapentin dose of 12.5 mg / kg oral 60 min before surgery - Midazolam 0.5 mg / kg oral 60 min before surgery.

Sponsors

Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged 3 to 12 years Candidate for tonsillectomy surgery Referred to Matini Hospital

Exclusion criteria

Exclusion criteria: Children with a history of allergy to any of the medications taken Children who themselves or their parents refuse to take the drug They had a history of using drugs affecting the central nervous system They had diseases affecting the central nervous system They needed emergency surgery It was estimated that their surgery would last more than one hour

Design outcomes

Primary

MeasureTime frame
Age, gender, weight, temperature, heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, headache, mask acceptance, parental separation, respiratory weakening, chills, double vision, forgetfulness, bleeding, nausea, vomiting. Timepoint: Before prescribing medication, during induction of anesthesia, recovery, discharge from operating room. Method of measurement: Age (year), gender (male and female), weight (kg), temperature (degree C), heart rate (number of minutes), respiratory rate (number of minutes), systolic blood pressure (mmHg) , Diastolic blood pressure (mmHg), headache (yes or no), mask acceptance (no problem or no problem), parental separation (easy or difficult), respiratory weakness (oxygen saturation), chills (yes or no), Double vision (yes or no), forgetfulness (yes or no), bleeding (yes or no), nausea (yes or no), vomiting (yes or no).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Shabani

Kashan University of Medical Sciences

mohammadshabaniii77@gmail.com+98 86 4422 0704

Outcome results

None listed

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