Does adding clonidine to local anesthetic reduce pain and emergence agitation (confusion and aggression that can occur when a person is coming round from general anesthesia) in children and young adults undergoing cleft lip and cleft palate repair surgery?

Clonidine as an adjuvant to bupivacaine for suprazygomatic maxillary nerve blocks in cleft lip and palate repair. A randomized, prospective, double-blind study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13265788

Enrollment

124

Registered

2020-01-16

Start date

2014-09-01

Completion date

Unknown

Last updated

2020-02-24

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

Conditions

Suprazygomatic maxillary nerve block in cleft lip and palate repair Surgery

Interventions

Patients were randomized after general anesthesia induction using a computerized randomized sequence in a 1:1 ratio in two parallel arms to receive bilateral suprazygomatic maxillary nerve blocks with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children or young adults aged 6 months or older 2. Scheduled for cleft lip or cleft palate surgery under general anesthesia between September and October 2014

Exclusion criteria

Exclusion criteria: 1. Lack of consent from patients or their parents 2. Allergy to local anesthetics 3. Coagulation disorders 4. Local infection or lesion at the proposed puncture site 5. Language difficulties 6. Cognitive disorders

Design outcomes

Primary

Measure	Time frame
Emergence agitation. Trained nurses scored the child’s level of agitation using the Watcha scale every 15 min during the first 45 min post-anesthesia. The Watcha Scale is a four-point scale with the highest overall sensitivity and specificity. A child with a score of >2 can be considered to have emergence agitation or delirium.	—

Secondary

Measure	Time frame
1. Pain score assessed at 0, 15, 30, 45, 60 min (every 15 min during the first hour), 90, 120, 150, 180 min (every 30 minutes until the patient was discharged from PACU), and at 4, 8, 12, 16, 20 and 24 h. The FLACC scale (Face, Legs, Activity, Cry, Consolability) was used to assess pain intensity in pediatric patients unable to report pain for themselves. In older patients pain was assessed using a numerical scale from 0 to 10 or by visual analogue scale (VAS), depending on patient characteristics. 2. Perioperative opioid use assessed by reviewing the anesthesia sheet and the patient's records during the entire perioperative period 3. Intraoperative hemodynamics assessed using anesthesia monitoring (non-invasive blood pressure and heart rate) by reviewing anesthesia records during the intraoperative period 4. Respiratory complications during the first 24 h assessed using SpO2 and clinical assessment during the postoperative period in the PACU and ward 5. Nerve block-related complications during the first 24 h assessed using intraoperative monitoring (local anesthetics toxicity and clonidine side effects), and clinical assessment (numbness, vascular puncture, aspiration test, hematoma formation, eye deviation, excessive drooling). Residual block-related complications were assessed at a 30-day follow-up visit by clinical assessment (hematoma formation, numbness, infection). Postoperative assessments were performed every 15 min during the first hour, every 30 min until the patient was discharged from PACU, and every 4 h during the first 24 h postoperatively. Residual block-related complications were assessed at a 30-day follow-up visit.	—

Measure

Time frame

1. Pain score assessed at 0, 15, 30, 45, 60 min (every 15 min during the first hour), 90, 120, 150, 180 min (every 30 minutes until the patient was discharged from PACU), and at 4, 8, 12, 16, 20 and 24 h. The FLACC scale (Face, Legs, Activity, Cry, Consolability) was used to assess pain intensity in pediatric patients unable to report pain for themselves. In older patients pain was assessed using a numerical scale from 0 to 10 or by visual analogue scale (VAS), depending on patient characteristics. 2. Perioperative opioid use assessed by reviewing the anesthesia sheet and the patient's records during the entire perioperative period 3. Intraoperative hemodynamics assessed using anesthesia monitoring (non-invasive blood pressure and heart rate) by reviewing anesthesia records during the intraoperative period 4. Respiratory complications during the first 24 h assessed using SpO2 and clinical assessment during the postoperative period in the PACU and ward 5. Nerve block-related complications during the first 24 h assessed using intraoperative monitoring (local anesthetics toxicity and clonidine side effects), and clinical assessment (numbness, vascular puncture, aspiration test, hematoma formation, eye deviation, excessive drooling). Residual block-related complications were assessed at a 30-day follow-up visit by clinical assessment (hematoma formation, numbness, infection). Postoperative assessments were performed every 15 min during the first hour, every 30 min until the patient was discharged from PACU, and every 4 h during the first 24 h postoperatively. Residual block-related complications were assessed at a 30-day follow-up visit.

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Countries

India

Outcome results

None listed

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